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

August 16, 2023 updated by: Penn State University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lipids (Total cholesterol, LDL-C, HDL-C, TG)
Time Frame: End of each 5 week diet period (weeks 5, 11, 17, 23)
End of each 5 week diet period (weeks 5, 11, 17, 23)

Secondary Outcome Measures

Outcome Measure
Time Frame
Apolipoprotein levels
Time Frame: End of each 5 week diet period (weeks 5, 11, 17, 23)
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)
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)
End of each 5 week diet period (weeks 5, 11, 17, 23)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penn State University

Collaborators

National Cattlemen's Beef Association

Investigators

  • Principal Investigator: Penny M Kris-Etherton, PhD, Penn State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

June 18, 2009

First Submitted That Met QC Criteria

July 10, 2009

First Posted (Estimated)

July 13, 2009

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKE101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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