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

This study has been completed.
Sponsor:
Collaborator:
National Cattlemen's Beef Association
Information provided by (Responsible Party):
Penny Kris-Etherton, Penn State University
ClinicalTrials.gov Identifier:
NCT00937898
First received: June 18, 2009
Last updated: May 13, 2013
Last verified: May 2013

June 18, 2009
May 13, 2013
August 2007
August 2011   (final data collection date for primary outcome measure)
Lipids (Total cholesterol, LDL-C, HDL-C, TG) [ Time Frame: End of each 5 week diet period (weeks 5, 11, 17, 23) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00937898 on ClinicalTrials.gov Archive Site
  • Apolipoprotein levels [ Time Frame: End of each 5 week diet period (weeks 5, 11, 17, 23) ] [ Designated as safety issue: No ]
  • Vascular function [ Time Frame: End of each 5 week diet period (weeks 5, 11, 17, 23) ] [ Designated as safety issue: No ]
  • Oxidative Stress [ Time Frame: End of each 5 week diet period (weeks 5, 11, 17, 23) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Beef in an Optimal Lean Diet (BOLD) Effects on Cardiovascular Disease (CVD) Risk
BOLD (Beef in an Optimal Lean Diet) Effects on Established and Emerging Cardiovascular Disease (CVD) Risk Factors

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Hypercholesterolemia
  • Hypertriglyceridemia
  • 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
  • Experimental: DASH Diet
    High fruit and vegetable, low sodium diet
    Interventions:
    • Dietary Supplement: BOLD+ Diet
    • Dietary Supplement: BOLD diet
  • Active Comparator: Average American Diet
    Typical American diet (16% protein, ~50% carbohydrate, 33% fat)
    Interventions:
    • Dietary Supplement: BOLD+ Diet
    • Dietary Supplement: BOLD diet
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2012
August 2011   (final data collection date for primary outcome measure)

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
Both
21 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00937898
PKE101
No
Penny Kris-Etherton, Penn State University
Penn State University
National Cattlemen's Beef Association
Principal Investigator: Penny M Kris-Etherton, PhD Penn State University
Penn State University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP