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

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ClinicalTrials.gov Identifier: NCT00937898
Recruitment Status : Completed
First Posted : July 13, 2009
Last Update Posted : May 15, 2013
Sponsor:
Collaborator:
National Cattlemen's Beef Association
Information provided by (Responsible Party):
Penny Kris-Etherton, Penn State University

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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Hypertriglyceridemia Dietary Supplement: BOLD+ Diet Dietary Supplement: BOLD diet Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: BOLD (Beef in an Optimal Lean Diet) Effects on Established and Emerging Cardiovascular Disease (CVD) Risk Factors
Study Start Date : August 2007
Actual Primary Completion Date : August 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DASH Diet
High fruit and vegetable, low sodium diet
Dietary Supplement: BOLD+ Diet
Comparison of lean beef based, high protein diet to DASH diet and Average American diet on cardiovascular disease risk factors

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

Active Comparator: Average American Diet
Typical American diet (16% protein, ~50% carbohydrate, 33% fat)
Dietary Supplement: BOLD+ Diet
Comparison of lean beef based, high protein diet to DASH diet and Average American diet on cardiovascular disease risk factors

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




Primary Outcome Measures :
  1. Lipids (Total cholesterol, LDL-C, HDL-C, TG) [ Time Frame: End of each 5 week diet period (weeks 5, 11, 17, 23) ]

Secondary Outcome Measures :
  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) ]


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00937898


Sponsors and Collaborators
Penn State University
National Cattlemen's Beef Association
Investigators
Principal Investigator: Penny M Kris-Etherton, PhD Penn State University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Penny Kris-Etherton, Distinguished Professor of Nutrition, Penn State University
ClinicalTrials.gov Identifier: NCT00937898     History of Changes
Other Study ID Numbers: PKE101
First Posted: July 13, 2009    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: May 2013

Keywords provided by Penny Kris-Etherton, Penn State University:
lean beef
cholesterol
lipids
diet intervention

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypercholesterolemia
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases