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

Purdue University

Status: Completed

Conditions: Diet Modification

Treatments: Other: Controlled healthy vegetarian diet; Other: Controlled beef diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03925142

1809021091

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 30 to 69 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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43 participants in 2 patient groups

Controlled healthy vegetarian diet

Active Comparator group

Description:

Subjects will be randomized and assigned to consume the controlled Healthy Vegetarian Eeating Pattern for 5 weeks.

Treatment:

Other: Controlled healthy vegetarian diet

Controlled beef diet

Experimental group

Description:

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.

Treatment:

Other: Controlled beef diet