Beef in an Optimal Lean Diet (BOLD) Effects on Cardiovascular Disease (CVD) Risk

Study Overview
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Brief Summary
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The study is designed to assess the effects of a heart-healthy diet that includes lean beef as the primary source of high quality protein on risk factors for cardiovascular disease.

Official Title
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BOLD (Beef in an Optimal Lean Diet) Effects on Established and Emerging Cardiovascular Disease (CVD) Risk Factors

Conditions
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Hypercholesterolemia, Hypertriglyceridemia

Intervention / Treatment
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* Dietary Supplement: BOLD+ Diet
* Dietary Supplement: BOLD diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI > 20 and < 37 LDL-C level between the 50th and 90th percentile (±5% for assay variation) according to NHANES data for sex and age (ex. for men: 128-177 mg/dL and for women: 121-172 mg/dL) TG level < 150 mg/dL Exclusion criteria include: self-reported history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease, and thyroid disease (unless controlled on medication) high alcohol consumption (≥ 14 drinks/week) intake of putative cholesterol-lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, and phytoestrogens, stanol/sterol supplemented foods) treatment with lipid-lowering agents (statins and fibrates) or blood pressure control medications vegetarian diet weight loss or gain ≥ 10% body weight in the previous 6 months, lactation, pregnancy, or desire to become pregnant during the study

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DASH Diet<br>High fruit and vegetable, low sodium diet | Dietary Supplement: BOLD+ Diet<br>* Comparison of lean beef based, high protein diet to DASH diet and Average American diet on cardiovascular disease risk factors<br>Dietary Supplement: BOLD diet<br>* Comparison of lean beef based diet to DASH diet and Average American diet on risk factors of cardiovascular disease<br>|
| Active Comparator: Average American Diet<br>Typical American diet (16% protein,  50% carbohydrate, 33% fat) | Dietary Supplement: BOLD+ Diet<br>* Comparison of lean beef based, high protein diet to DASH diet and Average American diet on cardiovascular disease risk factors<br>Dietary Supplement: BOLD diet<br>* Comparison of lean beef based diet to DASH diet and Average American diet on risk factors of cardiovascular disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipids (Total cholesterol, LDL-C, HDL-C, TG) |  | End of each 5 week diet period (weeks 5, 11, 17, 23) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apolipoprotein levels |  | End of each 5 week diet period (weeks 5, 11, 17, 23) | 
| Vascular function |  | End of each 5 week diet period (weeks 5, 11, 17, 23) | 
| Oxidative Stress |  | End of each 5 week diet period (weeks 5, 11, 17, 23) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lean beef, cholesterol, lipids, diet intervention