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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diet Modification

Intervention / Treatment
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* Other: Controlled healthy vegetarian diet
* Other: Controlled beef diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This is a 16-week randomized, cross-over, controlled, single-blind study. During weeks 1 and 11, participant's usual, unrestricted dietary intakes will be assessed. At week 2, they will be randomized and assigned to consume either the controlled lacto-ovo vegetarian diet or beef diet for the first 5-week dietary intervention during weeks 2-6. They will consume the other diet during weeks 12-16. Two fasting-state serum samples and one stool samples will be collected during study weeks 1,6,11, and 16.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Controlled healthy vegetarian diet<br>Subjects will be randomized and assigned to consume the controlled Healthy Vegetarian Eeating Pattern for 5 weeks. | Other: Controlled healthy vegetarian diet<br>* 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.<br>|
| Experimental: Controlled beef diet<br>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. | Other: Controlled beef diet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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beef, cardio-metabolic disease