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

Primary Purpose

Hypercholesterolemia, Hypertriglyceridemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BOLD+ Diet
BOLD diet
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypercholesterolemia focused on measuring lean beef, cholesterol, lipids, diet intervention

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    DASH Diet

    Average American Diet

    Arm Description

    High fruit and vegetable, low sodium diet

    Typical American diet (16% protein, ~50% carbohydrate, 33% fat)

    Outcomes

    Primary Outcome Measures

    Lipids (Total cholesterol, LDL-C, HDL-C, TG)

    Secondary Outcome Measures

    Apolipoprotein levels
    Vascular function
    Oxidative Stress

    Full Information

    First Posted
    June 18, 2009
    Last Updated
    August 16, 2023
    Sponsor
    Penn State University
    Collaborators
    National Cattlemen's Beef Association
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00937898
    Brief Title
    Beef in an Optimal Lean Diet (BOLD) Effects on Cardiovascular Disease (CVD) Risk
    Acronym
    BOLD
    Official Title
    BOLD (Beef in an Optimal Lean Diet) Effects on Established and Emerging Cardiovascular Disease (CVD) Risk Factors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2007 (undefined)
    Primary Completion Date
    August 2011 (Actual)
    Study Completion Date
    March 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Penn State University
    Collaborators
    National Cattlemen's Beef Association

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesterolemia, Hypertriglyceridemia
    Keywords
    lean beef, cholesterol, lipids, diet intervention

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DASH Diet
    Arm Type
    Experimental
    Arm Description
    High fruit and vegetable, low sodium diet
    Arm Title
    Average American Diet
    Arm Type
    Active Comparator
    Arm Description
    Typical American diet (16% protein, ~50% carbohydrate, 33% fat)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    BOLD+ Diet
    Intervention Description
    Comparison of lean beef based, high protein diet to DASH diet and Average American diet on cardiovascular disease risk factors
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    BOLD diet
    Intervention Description
    Comparison of lean beef based diet to DASH diet and Average American diet on risk factors of cardiovascular disease
    Primary Outcome Measure Information:
    Title
    Lipids (Total cholesterol, LDL-C, HDL-C, TG)
    Time Frame
    End of each 5 week diet period (weeks 5, 11, 17, 23)
    Secondary Outcome Measure Information:
    Title
    Apolipoprotein levels
    Time Frame
    End of each 5 week diet period (weeks 5, 11, 17, 23)
    Title
    Vascular function
    Time Frame
    End of each 5 week diet period (weeks 5, 11, 17, 23)
    Title
    Oxidative Stress
    Time Frame
    End of each 5 week diet period (weeks 5, 11, 17, 23)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: BMI > 20 and < 37 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) TG level < 150 mg/dL Exclusion criteria include: self-reported history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease, and thyroid disease (unless controlled on medication) high alcohol consumption (≥ 14 drinks/week) intake of putative cholesterol-lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, and phytoestrogens, stanol/sterol supplemented foods) treatment with lipid-lowering agents (statins and fibrates) or blood pressure control medications vegetarian diet weight loss or gain ≥ 10% body weight in the previous 6 months, lactation, pregnancy, or desire to become pregnant during the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Penny M Kris-Etherton, PhD
    Organizational Affiliation
    Penn State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22170364
    Citation
    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.
    Results Reference
    derived

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

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