NCT00937898CompletedNot Applicable
BOLD (Beef in an Optimal Lean Diet) Effects on Established and Emerging Cardiovascular Disease (CVD) Risk Factors
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Penn State University
- Enrollment
- 40
- Primary Endpoint
- Lipids (Total cholesterol, LDL-C, HDL-C, TG)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
Arms & Interventions
DASH Diet
Experimental
High fruit and vegetable, low sodium diet
Intervention: BOLD+ Diet (Dietary Supplement)
DASH Diet
Experimental
High fruit and vegetable, low sodium diet
Intervention: BOLD diet (Dietary Supplement)
Average American Diet
Active Comparator
Typical American diet (16% protein, ~50% carbohydrate, 33% fat)
Intervention: BOLD+ Diet (Dietary Supplement)
Average American Diet
Active Comparator
Typical American diet (16% protein, ~50% carbohydrate, 33% fat)
Intervention: BOLD diet (Dietary Supplement)
Outcomes
Primary Outcomes
Lipids (Total cholesterol, LDL-C, HDL-C, TG)
Time Frame: End of each 5 week diet period (weeks 5, 11, 17, 23)
Secondary Outcomes
- 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))
Investigators
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