Beef in an Optimal Lean Diet (BOLD) Effects on Cardiovascular Disease (CVD) Risk
BOLD
BOLD (Beef in an Optimal Lean Diet) Effects on Established and Emerging Cardiovascular Disease (CVD) Risk Factors
1 other identifier
interventional
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2007
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 18, 2009
CompletedFirst Posted
Study publicly available on registry
July 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedAugust 21, 2023
August 1, 2023
4 years
June 18, 2009
August 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lipids (Total cholesterol, LDL-C, HDL-C, TG)
End of each 5 week diet period (weeks 5, 11, 17, 23)
Secondary Outcomes (3)
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)
Study Arms (2)
DASH Diet
EXPERIMENTALHigh fruit and vegetable, low sodium diet
Average American Diet
ACTIVE COMPARATORTypical American diet (16% protein, \~50% carbohydrate, 33% fat)
Interventions
Comparison of lean beef based diet to DASH diet and Average American diet on risk factors of cardiovascular disease
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Roussell MA, Hill AM, Gaugler TL, West SG, Heuvel JP, Alaupovic P, Gillies PJ, Kris-Etherton PM. Beef in an Optimal Lean Diet study: effects on lipids, lipoproteins, and apolipoproteins. Am J Clin Nutr. 2012 Jan;95(1):9-16. doi: 10.3945/ajcn.111.016261. Epub 2011 Dec 14.
PMID: 22170364DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Penny M Kris-Etherton, PhD
Penn State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2009
First Posted
July 13, 2009
Study Start
August 1, 2007
Primary Completion
August 1, 2011
Study Completion
March 1, 2012
Last Updated
August 21, 2023
Record last verified: 2023-08