Effects of Replacing Starchy Vegetables and Refined Grains With Beef on Cardio-metabolic Disease Risk Factors (S53)

Diet Modification Clinical Trial

Official title:

Effects of Replacing Starchy Vegetables and Refined Grains With Beef in a Vegetarian Diet on Cardio-metabolic Disease Risk Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03925142
• Other study ID #: 1809021091
• Status: Completed
• Phase: N/A
• Start date: June 4, 2019
• Est. completion date: October 28, 2021

Study information

• Verified date: December 2021
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the effects of replacing starchy vegetables and refined grains with beef in a vegetarian diet on cardio-metabolic disease risk factors in adults in a cross-over, randomized controlled feeding trial.

Description:

The purpose of this study is to assess the effects of replacing starchy vegetables and refined grains with beef in a vegetarian diet on cardio-metabolic disease risk factors in adults in a cross-over, randomized controlled feeding trial. The hypothesis is that isocalorically replacing predominantly starchy vegetables and refined grains with 6 oz. of beef/day will enhance improvements in cardiometabolic disease risk factors, particularly atherosclerotic-promoting lipids and lipoproteins. It is also hypothesized that participant satisfaction and acceptance of a healthy eating pattern with 6 oz. of beef per day will be higher compared to without beef.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 28, 2021
• Est. primary completion date: October 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 69 Years

Eligibility

Inclusion Criteria:

• Male or female

• 30-69 years old

• BMI 25-37 kg/m2

• Total cholesterol <260 mg/dL

• Low-density lipoprotein cholesterol <190 mg/dL

• Glucose <110 mg/dL

• Systolic/diastolic blood pressure < 140/90

• Body weight stable for 3 months prior (±3 kg)

• Stable physical activity regimen 3 months prior

• Medication use stable for 6 months prior

• Non-smoking

• Not drinking more than 2 alcoholic drinks per day

• Non-diabetic

• Not lactose-intolerant

• Not acutely ill

• Non-pregnant and not lactating.

• Participants must be willing and able to consume the prescribed diets (lacto-ovo vegetarian and omnivorous).

Exclusion Criteria:

• <30 or >69 years old

• BMI <25.0 or >37 kg/m2

• Fasting serum total cholesterol > 260 mg/dL

• Low-density lipoprotein cholesterol >189 mg/dL

• Glucose >110 mg/dL

• Systolic/diastolic blood pressure > 140/90

• Body weight stable for <3 months prior (±3 kg)

• Stable physical activity regimen < 3 months prior

• Medication use unstable for 6 months prior and using medications

• Smoking

• Drinking more than 2 alcoholic drinks per day

• Diabetic

• Have renal failure

• Have liver failure

• Have cardiovascular events (myocardial infarction or stroke) during the 6 months prior to the study

• Pregnant or lactating

Related Conditions & MeSH terms

• Diet Modification
• Metabolic Diseases

Intervention

Other:
• Controlled healthy vegetarian diet
The controlled healthy vegetarian diet will follow the Dietary Guidelines for American's recommendations. All foods and beverages will be provided during intervention to achieve the desired eating pattern.
• Controlled beef diet
The controlled beef diet will incorporate various cuts of lean unprocessed red meat into the healthy vegetarian eating pattern, as approved by the American Heart Association's Food Certification Program. The beef diet will isocalorically replace starchy vegetables and/or refined grains with 6 oz. of beef/day for five weeks.

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Questionnaire score of consumer satisfaction of a plant-based eating pattern	The hypothesis is that substituting starchy vegetables and refined grain with lean unprocessed beef in a plant-based eating pattern will result in a higher score of consumer satisfaction using the Dietary Satisfaction Questionnaire designed by study investigators. The Dietary Satisfaction Questionnaire is a six-point Likert scale ranging from "strongly disagree" to "strongly agree". The questionnaire includes 23 questions on overall satisfaction of different aspects of the intervention diets, such as fullness after meals, enjoyment of study foods, and impact of study foods on personal well-being. The Likert scale will be matched to numerical values for scoring (0=strongly disagree, 1=disagree, 2=slightly disagree, 3=slightly agree, 4=agree, 5=strongly agree). Total score ranges from 0 to 115 and higher score represents higher dietary satisfaction.	1.5 years
Primary	Concentrations of serum lipids, lipoproteins, and total apolipoprotein B	The hypothesis is that substituting starchy vegetables and refined grain with lean unprocessed beef in a plant based eating pattern will result in greater reduction in the concentrations of low-density lipoprotein-cholesterol, total cholesterol, triglycerides, and total apolipoprotein B, but greater increase in concentration of high-density lipoprotein-cholesterol.	1.5 years
Secondary	Level of fasting blood pressure	The hypothesis is that substituting starchy vegetables and refined grain with lean unprocessed beef in a plantbased eating pattern will result in greater reductions in fasting blood pressure.	1.5 years
Secondary	Level of fasting serum insulin	The hypothesis is that substituting starchy vegetables and refined grain with lean unprocessed beef in a plantbased eating pattern will result in greater reductions in fasting serum insulin.	1.5 years
Secondary	Concentration of fasting serum glucose	The hypothesis is that substituting starchy vegetables and refined grain with lean unprocessed beef in a plantbased eating pattern will result in greater reductions in fasting serum glucose.	1.5 years
Secondary	Size of lipoprotein particle	The hypothesis is that substituting starchy vegetables and refined grain with lean unprocessed beef in a plantbased eating pattern will result in greater reductions in low-density lipoprotein particle size.	1.5 years