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Ground Beef and Cardiovascular Disease

Primary Purpose

Lipoprotein Metabolism Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ground beef
Sponsored by
Texas A&M University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Lipoprotein Metabolism Disorder focused on measuring ground beef, lipoprotein cholesterol, cardiovascular disease

Eligibility Criteria

23 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Non-smoking

Exclusion Criteria:

  • Consuming restrictive diets, cholesterol-lowering medications

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Low-MUFA ground beef

    High-MUFA ground beef

    Arm Description

    Participants consumed ground beef low in monounsaturated fatty acids.

    Participants consumed ground beef high in monounsaturated fatty acids.

    Outcomes

    Primary Outcome Measures

    Lipoprotein cholesterol
    Plasma very low-density, low-density, and high-density cholesterol concentrations
    Low-density lipoprotein particle size
    Plasma low-density lipoprotein particle size

    Secondary Outcome Measures

    C-reactive protein
    Plasma C-reactive protein

    Full Information

    First Posted
    June 25, 2021
    Last Updated
    June 25, 2021
    Sponsor
    Texas A&M University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04945980
    Brief Title
    Ground Beef and Cardiovascular Disease
    Official Title
    Manipulation of Beef Fatty Acids to Tailor Ground Beef Products to Individual Consumer Needs
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    March 27, 2006 (Actual)
    Primary Completion Date
    May 31, 2006 (Actual)
    Study Completion Date
    May 31, 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Texas A&M University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study tested the hypothesis that ground beef high in monounsaturated fat (MUFA) and low in saturated fat (SFA) would increase the high-density lipoprotein-cholesterol concentration and low-density lipoprotein particle diameter. In a crossover dietary intervention, 27 free-living normocholesterolemic men completed treatments in which five 114-g ground beef patties/week were consumed for 5 weeks with an intervening 4-week washout period. Patties contained 24% total fat with a MUFA:SFA ratio of either 0.71 (low MUFA, from pasture-fed cattle) or 1.10 (high MUFA, from grain-fed cattle).
    Detailed Description
    Participants and study design Healthy, nonsmoking males between the ages of 23 and 60 years were screened for eligibility. The 30 participants selected were not consuming restrictive diets or medications. Family histories were obtained as part of a complete physical examination that included a treadmill exercise test with an electrocardiogram. Baseline blood chemistries were analyzed by a local laboratory and all blood chemistries were within normal ranges as defined by the testing laboratory. All participants were free living and were instructed to maintain routine activities and body weight (62.2 kg of entry weight). Exercise and physical activities were not restricted, but participants were requested not to change their habitual level of physical activity. Twenty-seven of the initial 30 participants completed the study. Of the 3 non-completers, 1 had a re-occurrence of a previous illness, another relocated, and data from the 3rd was omitted following baseline samples that showed high triglyceride concentrations (.5 mmol/L). A 2-period, randomized cross-over design was used. Each participant completed two 5-wk diet interventions in a randomly assigned order with a 4-wk washout period between the test diet interventions. The men consumed 5 ground beef patties per week for 5 wk during each dietary intervention (25 patties of each type for each ground beef intervention). The 2 interventions were low-monounsaturated fat ground beef and high-monounsaturated fat ground beef. To facilitate product distribution and blood sampling, participants were assigned to 1 of 2 groups, which were balanced with regard to age, body weight, and total cholesterol concentration at the initial screening. Group 1 began the study 2 wk before group 2. Both groups rotated through both test diets, but the pattern in which they crossed over differed between groups. Therefore, crossovers included all possible rotation sequences. Body weights were recorded weekly. Collection and analysis of blood samples Prior to the initiation of the dietary treatments and at the end of each diet phase and after 5 minutes of seated rest, blood was collected from the participants into vacutainers from a vein in the antecubital fossa using standard phlebotomy procedures. Plasma was harvested from the blood collected with EDTA and lipoproteins preserved in plasma prior to lipoprotein separation using density gradient ultracentrifugation employing human density intervals. Determination of LDL lipoprotein diameters was by non-denaturing gradient gel electrophoresis. Particle diameters were determined by comparison with migration distances of standard proteins of known hydrated diameter. Plasma total lipoproteins isolated as the d < 1.2 kg/L fraction of plasma were separated on the basis of diameter with a gel-filtration chromatographic system to determine the relative distribution of plasma total cholesterol among very low-density lipoproteins (VLDL), LDL, and HDL lipoprotein classes. Concentrations of total cholesterol, triglycerides, and glucose in plasma were determined by separate enzymatic assays. Concentrations of serum insulin and serum C-reactive protein (CRP) were assayed using commercially available ELISA kits according to the manufacturers' instructions. Statistical analysis We compared nutrient and dietary exchange data and final plasma glucose, lipids, insulin, CRP, and lipoprotein particle diameters to their corresponding baseline values by paired t test. Data were tested for unequal variance by the Breusch- Pagan/Cook-Weisberg test for heteroscedasticity to test the null hypothesis that the error variances were all equal. Values for changes from baseline for the low- and high-MUFA treatment groups were compared by 1-way analysis of variance, with ground beef type as the treatment effect. Associations among plasma analytes were assessed using Pearson correlation coefficients. P-values were considered significant at P < 0.05.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lipoprotein Metabolism Disorder
    Keywords
    ground beef, lipoprotein cholesterol, cardiovascular disease

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    A 2-period, randomized cross-over design was used. Each participant completed two 5-wk diet interventions in a randomly assigned order with a 4-wk washout period between the test diet interventions.
    Masking
    Participant
    Masking Description
    Participants were blinded to treatments.
    Allocation
    Randomized
    Enrollment
    27 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Low-MUFA ground beef
    Arm Type
    Experimental
    Arm Description
    Participants consumed ground beef low in monounsaturated fatty acids.
    Arm Title
    High-MUFA ground beef
    Arm Type
    Experimental
    Arm Description
    Participants consumed ground beef high in monounsaturated fatty acids.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Ground beef
    Intervention Description
    Ground beef naturally low in monounsaturated fatty acids or naturally high in monounsaturated fatty acids
    Primary Outcome Measure Information:
    Title
    Lipoprotein cholesterol
    Description
    Plasma very low-density, low-density, and high-density cholesterol concentrations
    Time Frame
    5 weeks
    Title
    Low-density lipoprotein particle size
    Description
    Plasma low-density lipoprotein particle size
    Time Frame
    5 weeks
    Secondary Outcome Measure Information:
    Title
    C-reactive protein
    Description
    Plasma C-reactive protein
    Time Frame
    5 weeks

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Gender Eligibility Description
    Males
    Minimum Age & Unit of Time
    23 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Non-smoking Exclusion Criteria: Consuming restrictive diets, cholesterol-lowering medications
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stephen Smith, Ph.D.
    Organizational Affiliation
    Texas A&M University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21525253
    Citation
    Gilmore LA, Walzem RL, Crouse SF, Smith DR, Adams TH, Vaidyanathan V, Cao X, Smith SB. Consumption of high-oleic acid ground beef increases HDL-cholesterol concentration but both high- and low-oleic acid ground beef decrease HDL particle diameter in normocholesterolemic men. J Nutr. 2011 Jun;141(6):1188-94. doi: 10.3945/jn.110.136085. Epub 2011 Apr 27.
    Results Reference
    result

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    Ground Beef and Cardiovascular Disease

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