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Completed

NCT Number: NCT00937898

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

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Hypertriglyceridemia Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BOLD+ Diet

Dietary Supplement

Comparison of lean beef based, high protein diet to DASH diet and Average American diet on cardiovascular disease risk factors

BOLD diet

Dietary Supplement

Comparison of lean beef based diet to DASH diet and Average American diet on risk factors of cardiovascular disease

Primary outcomes

  1. Lipids (Total cholesterol, LDL-C, HDL-C, TG)

    Time frame: End of each 5 week diet period (weeks 5, 11, 17, 23)

Secondary outcomes

  1. Apolipoprotein levels

    Time frame: End of each 5 week diet period (weeks 5, 11, 17, 23)

  2. Vascular function

    Time frame: End of each 5 week diet period (weeks 5, 11, 17, 23)

  3. Oxidative Stress

    Time frame: End of each 5 week diet period (weeks 5, 11, 17, 23)

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • National Cattlemen's Beef Association, a contractor to the Beef Checkoff

Registry information

Official study title

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

Acronym: BOLD

Important dates

Study start
2007
Primary completion
2011
Study completion
2012
First posted
Jul 13, 2009
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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