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
  Purpose

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 Intervention
Hypercholesterolemia
Hypertriglyceridemia
Dietary Supplement: BOLD+ Diet
Dietary Supplement: BOLD diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: BOLD (Beef in an Optimal Lean Diet) Effects on Established and Emerging Cardiovascular Disease (CVD) Risk Factors

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: August 2007
Study Completion Date: March 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937898

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

No publications provided by Penn State University

Additional 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
Study First Received: June 18, 2009
Last Updated: May 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
lean beef
cholesterol
lipids
diet intervention

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

ClinicalTrials.gov processed this record on April 17, 2014