Ground Beef and Cardiovascular Disease
Primary Purpose
Lipoprotein Metabolism Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ground beef
Sponsored by
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
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
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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