Meat And Dietary Pattern Study

Healthy Volunteers Clinical Trial

Official title:

HS68-Meat And Pattern Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05589389
• Other study ID #: HS68 - Meat And Pattern Study
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 26, 2022
• Est. completion date: July 30, 2025

Study information

• Verified date: November 2023
• Source: USDA Beltsville Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to investigate how different types of meat consumed with two different dietary patterns affect risk for disease.

Description:

Association studies have suggested that dietary meat intake may have negative impacts on health. However, these association studies have done a poor job separating meat intake from overall dietary pattern, as well as isolating effects of processed meat from minimally processed meat. Meat is a good source of several essential nutrients, including high quality protein, iron, and vitamin B12. This dietary intervention is designed to investigate the effects of minimally processed meat and further proceeded meat, as part of two different dietary patterns (the typical American dietary pattern and Dietary Guidelines dietary pattern) on outcomes related to chronic diseases.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: July 30, 2025
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male or female

Exclusion Criteria:

• Younger than 25 years old and older than 80 years old at the beginning of the intervention.

• Body mass index less than 18 or greater than 40 kg/m2.

• Blood pressure greater than 160/100 mm Hg or use of medication to treat hypertension for less than 6 months.

• Use of medications that will affect the study outcomes, including cholesterol lowering medications.

• Pregnant women, lactating women, women who plan to become pregnant during the study, or women who have given birth during the previous 12 months.

• Fasting blood glucose over 125 mg/dL or type 2 diabetes requiring medication.

• Body weight change of 10% in the past 3 months.

• History of bariatric or other gastrointestinal surgery that would affect digestion.

• History or presence of diabetes, kidney disease, liver disease, certain cancers, gout, hyperthyroidism, untreated or unstable hypothyroidism, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes.

• Smokers, vapers, or other tobacco users (within 6 months prior to the start of the study).

• Use of an antibiotic within 1 month of the start of the study or during the study.

• Plans to have a colonoscopy during the study.

• Allergy to any food included in the study menus.

• Unable or unwilling to give informed consent or communicate with study staff.

• Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion).

• Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• High Healthy Eating Index Diet with Minimally Processed Meat
Participants will consume a diet with a high Healthy Eating Index along with meat that is minimally processed.
• High Healthy Eating Index Diet with Further Processed Meat
Participants will consume a diet with a high Healthy Eating Index along with meat that is further processed.
• Typical Healthy Eating Index Diet with Minimally Processed Meat
Participants will consume a diet with a typical Healthy Eating Index along with meat that is minimally processed.
• Typical Healthy Eating Index Diet with Further Processed Meat
Participants will consume a diet with a typical Healthy Eating Index along with meat that is further processed.

Locations

Country	Name	City	State
United States	USDA-ARS, Beltsville Human Nutrition Research Center	Beltsville	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
USDA Beltsville Human Nutrition Research Center	National Cattlemen's Beef Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carnitine Concentration	Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 1
Primary	Carnitine Concentration	Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 2
Primary	Carnitine Concentration	Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 35
Primary	Carnitine Concentration	Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 36
Primary	Carnitine Concentration	Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 70
Primary	Carnitine Concentration	Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 71
Primary	Carnitine Concentration	Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 105
Primary	Carnitine Concentration	Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 106
Primary	Carnitine Concentration	Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 140
Primary	Carnitine Concentration	Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 141
Primary	Choline Concentration	Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 1
Primary	Choline Concentration	Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 2
Primary	Choline Concentration	Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 35
Primary	Choline Concentration	Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 36
Primary	Choline Concentration	Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 70
Primary	Choline Concentration	Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 71
Primary	Choline Concentration	Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 105
Primary	Choline Concentration	Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 106
Primary	Choline Concentration	Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 140
Primary	Choline Concentration	Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 141
Primary	Betaine Concentration	Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 1
Primary	Betaine Concentration	Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 2
Primary	Betaine Concentration	Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 35
Primary	Betaine Concentration	Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 36
Primary	Betaine Concentration	Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 70
Primary	Betaine Concentration	Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 71
Primary	Betaine Concentration	Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 105
Primary	Betaine Concentration	Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 106
Primary	Betaine Concentration	Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 140
Primary	Betaine Concentration	Betaine, which help make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 141
Primary	TMA (trimethylamine) Concentration	TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 1
Primary	TMA (trimethylamine) Concentration	TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 2
Primary	TMA (trimethylamine) Concentration	TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 35
Primary	TMA (trimethylamine) Concentration	TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 36
Primary	TMA (trimethylamine) Concentration	TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 70
Primary	TMA (trimethylamine) Concentration	TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 71
Primary	TMA (trimethylamine) Concentration	TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 105
Primary	TMA (trimethylamine) Concentration	TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 106
Primary	TMA (trimethylamine) Concentration	TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 140
Primary	TMA (trimethylamine) Concentration	TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 141
Primary	TMAO (trimethylamine N-oxide) Concentration	TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 1
Primary	TMAO (trimethylamine N-oxide) Concentration	TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 2
Primary	TMAO (trimethylamine N-oxide) Concentration	TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 35
Primary	TMAO (trimethylamine N-oxide) Concentration	TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 36
Primary	TMAO (trimethylamine N-oxide) Concentration	TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 70
Primary	TMAO (trimethylamine N-oxide) Concentration	TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 71
Primary	TMAO (trimethylamine N-oxide) Concentration	TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 105
Primary	TMAO (trimethylamine N-oxide) Concentration	TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 106
Primary	TMAO (trimethylamine N-oxide) Concentration	TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 140
Primary	TMAO (trimethylamine N-oxide) Concentration	TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.	Day 141
Primary	Total Cholesterol Concentration	Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 1
Primary	Total Cholesterol Concentration	Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 2
Primary	Total Cholesterol Concentration	Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 35
Primary	Total Cholesterol Concentration	Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 36
Primary	Total Cholesterol Concentration	Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 70
Primary	Total Cholesterol Concentration	Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 71
Primary	Total Cholesterol Concentration	Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 105
Primary	Total Cholesterol Concentration	Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 106
Primary	Total Cholesterol Concentration	Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 140
Primary	Total Cholesterol Concentration	Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 141
Primary	LDL Cholesterol Concentration	LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 1
Primary	LDL Cholesterol Concentration	LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 2
Primary	LDL Cholesterol Concentration	LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 35
Primary	LDL Cholesterol Concentration	LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 36
Primary	LDL Cholesterol Concentration	LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 70
Primary	LDL Cholesterol Concentration	LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 71
Primary	LDL Cholesterol Concentration	LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 105
Primary	LDL Cholesterol Concentration	LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 106
Primary	LDL Cholesterol Concentration	LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 140
Primary	LDL Cholesterol Concentration	LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 141
Primary	HDL Cholesterol Concentration	HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 1
Primary	HDL Cholesterol Concentration	HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 2
Primary	HDL Cholesterol Concentration	HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 35
Primary	HDL Cholesterol Concentration	HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 36
Primary	HDL Cholesterol Concentration	HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 70
Primary	HDL Cholesterol Concentration	HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 71
Primary	HDL Cholesterol Concentration	HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 105
Primary	HDL Cholesterol Concentration	HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 106
Primary	HDL Cholesterol Concentration	HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 140
Primary	HDL Cholesterol Concentration	HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 141
Primary	Triglyceride Concentration	Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 1
Primary	Triglyceride Concentration	Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 2
Primary	Triglyceride Concentration	Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 35
Primary	Triglyceride Concentration	Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 36
Primary	Triglyceride Concentration	Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 70
Primary	Triglyceride Concentration	Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 71
Primary	Triglyceride Concentration	Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 105
Primary	Triglyceride Concentration	Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 106
Primary	Triglyceride Concentration	Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 140
Primary	Triglyceride Concentration	Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 141
Primary	Apolipoprotein Concentration	Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 1
Primary	Apolipoprotein Concentration	Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 2
Primary	Apolipoprotein Concentration	Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 35
Primary	Apolipoprotein Concentration	Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 36
Primary	Apolipoprotein Concentration	Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 70
Primary	Apolipoprotein Concentration	Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 71
Primary	Apolipoprotein Concentration	Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 105
Primary	Apolipoprotein Concentration	Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 106
Primary	Apolipoprotein Concentration	Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 140
Primary	Apolipoprotein Concentration	Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 141
Primary	Lipoprotein(a) (Lp(a)) Concentration	Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 1
Primary	Lipoprotein(a) (Lp(a)) Concentration	Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 2
Primary	Lipoprotein(a) (Lp(a)) Concentration	Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 35
Primary	Lipoprotein(a) (Lp(a)) Concentration	Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 36
Primary	Lipoprotein(a) (Lp(a)) Concentration	Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 70
Primary	Lipoprotein(a) (Lp(a)) Concentration	Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 71
Primary	Lipoprotein(a) (Lp(a)) Concentration	Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 105
Primary	Lipoprotein(a) (Lp(a)) Concentration	Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 106
Primary	Lipoprotein(a) (Lp(a)) Concentration	Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 140
Primary	Lipoprotein(a) (Lp(a)) Concentration	Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.	Day 141
Primary	Low Density Lipoprotein particle size	Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.	Day 1
Primary	Low Density Lipoprotein particle size	Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.	Day 2
Primary	Low Density Lipoprotein particle size	Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.	Day 35
Primary	Low Density Lipoprotein particle size	Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.	Day 36
Primary	Low Density Lipoprotein particle size	Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.	Day 70
Primary	Low Density Lipoprotein particle size	Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.	Day 71
Primary	Low Density Lipoprotein particle size	Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.	Day 105
Primary	Low Density Lipoprotein particle size	Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.	Day 106
Primary	Low Density Lipoprotein particle size	Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.	Day 140
Primary	Low Density Lipoprotein particle size	Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.	Day 141
Primary	Blood Pressure	Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.	Day 1
Primary	Blood Pressure	Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.	Day 2
Primary	Blood Pressure	Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.	Day 35
Primary	Blood Pressure	Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.	Day 36
Primary	Blood Pressure	Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.	Day 70
Primary	Blood Pressure	Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.	Day 71
Primary	Blood Pressure	Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.	Day 105
Primary	Blood Pressure	Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.	Day 106
Primary	Blood Pressure	Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.	Day 140
Primary	Blood Pressure	Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.	Day 141
Secondary	Gut microbiota	Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).	Day 1
Secondary	Gut microbiota	Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).	Day 2
Secondary	Gut microbiota	Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).	Day 35
Secondary	Gut microbiota	Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).	Day 36
Secondary	Gut microbiota	Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).	Day 70
Secondary	Gut microbiota	Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).	Day 71
Secondary	Gut microbiota	Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).	Day 105
Secondary	Gut microbiota	Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).	Day 106
Secondary	Gut microbiota	Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).	Day 140
Secondary	Gut microbiota	Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).	Day 141
Secondary	Bile acid Concentration	Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.	Day 1
Secondary	Bile acid Concentration	Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.	Day 2
Secondary	Bile acid Concentration	Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.	Day 35
Secondary	Bile acid Concentration	Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.	Day 36
Secondary	Bile acid Concentration	Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.	Day 70
Secondary	Bile acid Concentration	Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.	Day 71
Secondary	Bile acid Concentration	Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.	Day 105
Secondary	Bile acid Concentration	Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.	Day 106
Secondary	Bile acid Concentration	Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.	Day 140
Secondary	Bile acid Concentration	Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.	Day 141
Secondary	Glucose Concentration	Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.	Day 1
Secondary	Glucose Concentration	Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.	Day 2
Secondary	Glucose Concentration	Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.	Day 35
Secondary	Glucose Concentration	Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.	Day 36
Secondary	Glucose Concentration	Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.	Day 70
Secondary	Glucose Concentration	Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.	Day 71
Secondary	Glucose Concentration	Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.	Day 105
Secondary	Glucose Concentration	Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.	Day 106
Secondary	Glucose Concentration	Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.	Day 140
Secondary	Glucose Concentration	Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.	Day 141
Secondary	Insulin Concentration	Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.	Day 1
Secondary	Insulin Concentration	Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.	Day 2
Secondary	Insulin Concentration	Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.	Day 35
Secondary	Insulin Concentration	Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.	Day 36
Secondary	Insulin Concentration	Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.	Day 70
Secondary	Insulin Concentration	Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.	Day 71
Secondary	Insulin Concentration	Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.	Day 105
Secondary	Insulin Concentration	Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.	Day 106
Secondary	Insulin Concentration	Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.	Day 140
Secondary	Insulin Concentration	Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.	Day 141
Secondary	Diet Satisfaction	Diet satisfaction will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters, with higher values representing higher satisfaction.	Week 1
Secondary	Diet Satisfaction	Diet satisfaction will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters, with higher values representing higher satisfaction.	Week 4
Secondary	Diet Satisfaction	Diet satisfaction will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters, with higher values representing higher satisfaction.	Week 5
Secondary	Diet Satisfaction	Diet satisfaction will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters, with higher values representing higher satisfaction.	Week 9
Secondary	Diet Satisfaction	Diet satisfaction will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters, with higher values representing higher satisfaction.	Week 10
Secondary	Diet Satisfaction	Diet satisfaction will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters, with higher values representing higher satisfaction.	Week 14
Secondary	Diet Satisfaction	Diet satisfaction will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters, with higher values representing higher satisfaction.	Week 15
Secondary	Diet Satisfaction	Diet satisfaction will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters, with higher values representing higher satisfaction.	Week 19
Secondary	Hunger and Satiety	Hunger and satiety will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters. Higher mm values for hunger indicate greater hunger; higher mm values for satiety indicate greater satiety.	Week 1
Secondary	Hunger and Satiety	Hunger and satiety will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters. Higher mm values for hunger indicate greater hunger; higher mm values for satiety indicate greater satiety.	Week 4
Secondary	Hunger and Satiety	Hunger and satiety will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters. Higher mm values for hunger indicate greater hunger; higher mm values for satiety indicate greater satiety.	Week 5
Secondary	Hunger and Satiety	Hunger and satiety will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters. Higher mm values for hunger indicate greater hunger; higher mm values for satiety indicate greater satiety.	Week 9
Secondary	Hunger and Satiety	Hunger and satiety will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters. Higher mm values for hunger indicate greater hunger; higher mm values for satiety indicate greater satiety.	Week 10
Secondary	Hunger and Satiety	Hunger and satiety will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters. Higher mm values for hunger indicate greater hunger; higher mm values for satiety indicate greater satiety.	Week 14
Secondary	Hunger and Satiety	Hunger and satiety will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters. Higher mm values for hunger indicate greater hunger; higher mm values for satiety indicate greater satiety.	Week 15
Secondary	Hunger and Satiety	Hunger and satiety will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters. Higher mm values for hunger indicate greater hunger; higher mm values for satiety indicate greater satiety.	Week 19
Secondary	24-Hour Dietary Recall	Prior to the start of the intervention, a 24-hour dietary recall interview will be conducted to assess food intake during the previous day. Data will be expressed as specific foods and how much of each food (grams) was consumed. The assessment will occur prior to the start of the dietary intervention, during baseline measurements, at approximately 5 to 7 days, and at approximately 3 to 5 days, and at approximately 1 to 3 days before the start of the dietary intervention (week 1).	5 to 7 days before Day 1
Secondary	24-Hour Dietary Recall	Prior to the start of the intervention, a 24-hour dietary recall interview will be conducted to assess food intake during the previous day. Data will be expressed as specific foods and how much of each food (grams) was consumed. The assessment will occur prior to the start of the dietary intervention, during baseline measurements, at approximately 5 to 7 days, and at approximately 3 to 5 days, and at approximately 1 to 3 days before the start of the dietary intervention (week 1).	3 to 5 days before Day 1
Secondary	24-Hour Dietary Recall	Prior to the start of the intervention, a 24-hour dietary recall interview will be conducted to assess food intake during the previous day. Data will be expressed as specific foods and how much of each food (grams) was consumed. The assessment will occur prior to the start of the dietary intervention, during baseline measurements, at approximately 5 to 7 days, and at approximately 3 to 5 days, and at approximately 1 to 3 days before the start of the dietary intervention (week 1).	1 to 3 days before Day 1
Secondary	IL6 Concentration	IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.	Day 1
Secondary	IL6 Concentration	IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.	Day 2
Secondary	IL6 Concentration	IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.	Day 35
Secondary	IL6 Concentration	IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.	Day 36
Secondary	IL6 Concentration	IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.	Day 70
Secondary	IL6 Concentration	IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.	Day 71
Secondary	IL6 Concentration	IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.	Day 105
Secondary	IL6 Concentration	IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.	Day 106
Secondary	IL6 Concentration	IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.	Day 140
Secondary	IL6 Concentration	IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.	Day 141
Secondary	C-Reactive Protein (CRP) Concentration	C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 1
Secondary	C-Reactive Protein (CRP) Concentration	C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 2
Secondary	C-Reactive Protein (CRP) Concentration	C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 35
Secondary	C-Reactive Protein (CRP) Concentration	C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 36
Secondary	C-Reactive Protein (CRP) Concentration	C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 70
Secondary	C-Reactive Protein (CRP) Concentration	C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 71
Secondary	C-Reactive Protein (CRP) Concentration	C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 105
Secondary	C-Reactive Protein (CRP) Concentration	C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 106
Secondary	C-Reactive Protein (CRP) Concentration	C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 140
Secondary	C-Reactive Protein (CRP) Concentration	C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 141
Secondary	Serum Amyloid A Concentration	Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 1
Secondary	Serum Amyloid A Concentration	Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 2
Secondary	Serum Amyloid A Concentration	Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 35
Secondary	Serum Amyloid A Concentration	Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 36
Secondary	Serum Amyloid A Concentration	Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 70
Secondary	Serum Amyloid A Concentration	Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 71
Secondary	Serum Amyloid A Concentration	Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 105
Secondary	Serum Amyloid A Concentration	Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 106
Secondary	Serum Amyloid A Concentration	Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 140
Secondary	Serum Amyloid A Concentration	Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.	Day 141