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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014