We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00937898
First Posted: July 13, 2009
Last Update Posted: May 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cattlemen's Beef Association
Information provided by (Responsible Party):
Penny Kris-Etherton, Penn State University
  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
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

Resource links provided by NLM:


Further study details as provided by Penny Kris-Etherton, 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) ]

Secondary Outcome Measures:
  • Apolipoprotein levels [ Time Frame: End of each 5 week diet period (weeks 5, 11, 17, 23) ]
  • Vascular function [ Time Frame: End of each 5 week diet period (weeks 5, 11, 17, 23) ]
  • Oxidative Stress [ Time Frame: End of each 5 week diet period (weeks 5, 11, 17, 23) ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 65 Years   (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
  Contacts and Locations
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
  More Information

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 Submitted: June 18, 2009
First Posted: July 13, 2009
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