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

The Pennsylvania State University (PENNSTATE)

Status: Completed

Conditions: Hypertriglyceridemia; Hypercholesterolemia

Treatments: Dietary Supplement: BOLD diet; Dietary Supplement: BOLD+ Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT00937898

PKE101

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. BMI > 20 and < 37
2. 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)
3. TG level < 150 mg/dL

Exclusion criteria include:

1. self-reported history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease, and thyroid disease (unless controlled on medication)
2. high alcohol consumption (≥ 14 drinks/week)
3. intake of putative cholesterol-lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, and phytoestrogens, stanol/sterol supplemented foods)
4. treatment with lipid-lowering agents (statins and fibrates) or blood pressure control medications
5. vegetarian diet
6. weight loss or gain ≥ 10% body weight in the previous 6 months,
7. lactation, pregnancy, or desire to become pregnant during the study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

DASH Diet

Experimental group

Description:

High fruit and vegetable, low sodium diet

Treatment:

Dietary Supplement: BOLD+ Diet

Dietary Supplement: BOLD diet

Average American Diet

Active Comparator group

Description:

Typical American diet (16% protein, \~50% carbohydrate, 33% fat)

Treatment:

Dietary Supplement: BOLD+ Diet

Dietary Supplement: BOLD diet