Lipoprotein Effects of Substituting Beef Protein for Carbohydrate

Study Overview
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Brief Summary
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The purpose of this study is to test whether replacing dietary carbohydrate with protein, using beef as the primarily source of protein, will improve risk factors for cardiovascular disease.

Detailed Description
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The primary aim of this study is to test the hypothesis that replacing dietary carbohydrate with protein, using beef as the primarily source of protein, will have beneficial effects on components of atherogenic dyslipidemia and postprandial lipoprotein response and that these effects will be independent of saturated fat intake.

Official Title
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Lipoprotein Effects of Substituting Beef Protein for Carbohydrate

Conditions
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Healthy, Cardiovascular Disease, Atherogenic Dyslipidemia

Intervention / Treatment
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* Other: High Carbohydrate, High Saturated Fat Diet
* Other: Low Carbohydrate, High Saturated Fat Diet
* Other: Low Carbohydrate, Low Saturated Fat Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Blood pressure less than 150/90 Body mass index (BMI)≥ 20 and ≤ 35 kg/m2 Non-smoker Agrees not to consume alcohol during the study Agrees to abstain from taking dietary supplements during the study LDL-cholesterol and total cholesterol < 95th percentile for age and sex Fasting triglycerides < 500 mg/dL Fasting glucose concentration < 126 mg/dL Hematocrit (HCT) ≥ 36% At least three months of a weight-stable state (± 3% of body weight) Exclusion Criteria: Personal history of coronary heart disease, cerebrovascular disease, peripheral vascular disease, diabetes, lung disease, bleeding disorder, liver or renal disease, HIV or of cancer (other than skin cancer) in the last five years Taking drugs known to affect lipid metabolism or insulin resistance, hormones, or the blood thinning agent warfarin Abnormal thyroid stimulating hormone (TSH) Strength trains with resistance weights more than four hours per week

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High CHO, High SatFat Diet<br> | Other: High Carbohydrate, High Saturated Fat Diet<br>* 50% Carbohydrate; 12% Protein; 38% Fat (15% Saturated Fat; 15% Monounsaturated Fat)<br>|
| Experimental: Low CHO, High SatFat Diet<br> | Other: Low Carbohydrate, High Saturated Fat Diet<br>* 31% Carbohydrate; 31% Protein; 38% Fat (15% Saturated Fat; 14% Monounsaturated Fat)<br>|
| Experimental: Low CHO, Low SatFat Diet<br> | Other: Low Carbohydrate, Low Saturated Fat Diet<br>* 31% Carbohydrate; 31% Protein; 38% Fat (8% Saturated Fat; 21% Monounsaturated Fat)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Cholesterol |  | 3 weeks, 8 weeks, and 13 weeks | 
| Non-HDL Cholesterol |  | 3 weeks, 8 weeks, and 13 weeks | 
| Apolipoprotein B |  | 3 weeks, 8 weeks, and 13 weeks | 
| LDL-Cholesterol/HDL-Cholesterol |  | 3 weeks, 8 weeks, and 13 weeks | 
| Apolipoprotein B/Apolipoprotein AI |  | 3 weeks, 8 weeks, and 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL peak diameter |  | 3 weeks, 8 weeks, and 13 weeks | 
| LDL subclass 3 (LDL3) |  | 3 weeks, 8 weeks, and 13 weeks | 
| HDL subclass 2 (HDL2) |  | 3 weeks, 8 weeks, and 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholesterol, diet, protein, carbohydrate, saturated fat, LDL subclass, healthy volunteers