A Comparison of the Effects on Cardiovascular Risk Factors of Korean and American Dietary Profiles

Hypercholesterolemia Clinical Trial

Official title:

A Comparison of the Effects on Cardiovascular Risk Factors of Korean and American Dietary Profiles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01617525
• Other study ID #: Korean Diet Study
• Status: Completed
• Phase: N/A
• First received: March 31, 2012
• Last updated: May 10, 2016
• Start date: January 2012
• Est. completion date: May 2012

Study information

• Verified date: May 2016
• Source: USDA Beltsville Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The primary aim of this study is to compare, in a group of at-risk individuals, the role of three dietary patterns on indices of Cardiovascular Disease (CVD) risk: a) the recommended Korean pattern; b) the typical American diet, based on national dietary intake surveys; and c) the 2010 DGA diet pattern. A secondary aim will be to assess the effects of each diet on intestinal microbiota and on inflammatory biomarkers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• Non Asian-American men and women between the ages of 25-65 years

• Body Mass Index (BMI) = 25 and = 38 kg/m2

• Fasting LDL-cholesterol = 130 mg/dL

• Willingness and ability to make scheduled appointments at clinical site as required by study protocol

Exclusion Criteria:

• Major aversions to Korean foods

• Known food allergies that would interfere with study protocol

• Use of cholesterol-lowering medication or dietary supplements

• Use of blood pressure medications

• Use of prebiotics or probiotics in the last 3 months

• Received medication for bacterial infection (antibiotic) in the last 3 months

• Regular use of fiber supplements or laxatives

• Conditions requiring ongoing medical care and/or medication, including kidney, liver, gastrointestinal or endocrine disorders.

• Regular tobacco use within 6 months prior to the start of the study

• History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)

• Voluntary or involuntary weight loss of 10% of body weight within the last 12 months

• Self-report of alcohol or substance abuse within the past 12 months

• Donated blood during the 8 week period prior to the study

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Other:
• Controlled Feeding Dietary Intervention
All meals will be provided during each 4-week intervention period. Participants must consume all foods provided and must not consume any outside foods during each intervention period.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
USDA Beltsville Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular Disease Biomarkers	Plasma total cholesterol, HDL and LDL cholesterol, insulin, glucose, and serum triglycerides will be measured.	End of each 4-week diet period	No
Secondary	Inflammatory Markers	Cytokine production will be analyzed by selecting representative pro-inflammatory cytokine genes (i.e. TNF-a, IL-12, IL-6, IFNg), anti-inflammatory genes (IL-10), and different signaling pathways (i.e. Mitogen activated protein kinase (MAPK) p38, phosphatidylinositol 3 (PI3) kinase, and nuclear factor Kappa B (NF-KB).	End of each 4-week diet	No
Secondary	Markers of appetite and food intake regulation	Plasma adiponectin, ghrelin, PYY and leptin will be measured.	End of each 4-week diet	No
Secondary	Blood pressure		End of each 4-week diet	No
Secondary	Urinary sodium excretion, potassium, urea nitrogen, phosphorus, and creatinine		End of each 4-week diet	No
Secondary	Change in fecal microbiota	Fecal samples will be collected to study changes in bacterial abundance of commensal microorganisms such as Bifidobacterium spp., Lactobacillus spp., E.coli spp. and Bacteroides fragilis spp.	At baseline and after 4-weeks of each diet	No
Secondary	Dietary Questionnaires	Participants will be asked to complete questionnaires regarding acceptability, satiety, and gastrointestinal symptoms.	At end of each 4-week diet	No