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

Not Applicable

Completed

• Conditions: Diet Modification
• Interventions: Other: Controlled healthy vegetarian diet; Other: Controlled beef diet

• Registration Number: NCT03925142
• Lead Sponsor: Purdue University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-22
• Study First Posted: 2019-04-24
• Study Start: 2019-06-04
• Primary Completion: 2021-10-28
• Study Completion: 2021-10-28
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-07
• Last Update Posted: 2021-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Controlled healthy vegetarian diet	Controlled healthy vegetarian diet	Subjects will be randomized and assigned to consume the controlled Healthy Vegetarian Eeating Pattern for 5 weeks.
Controlled beef diet	Controlled beef diet	Subjects will be randomized and assigned to consume the beef diet for 5 weeks, which will substitute predominantly starchy vegetables and refined grains with 6 oz. of lean unprocessed beef/day.

Primary Outcome Measures

Name	Time	Method
Concentrations of serum lipids, lipoproteins, and total apolipoprotein B	1.5 years	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.

Secondary Outcome Measures

Name	Time	Method
Level of fasting blood pressure	1.5 years	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.
Concentration of fasting serum glucose	1.5 years	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.
Level of fasting serum insulin	1.5 years	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.
Size of lipoprotein particle	1.5 years	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.

Trial Locations

Locations (1)

Purdue University; 🇺🇸 West Lafayette, Indiana, United States