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Lipoprotein Metabolism DisorderNCT04945980

Ground Beef and Cardiovascular Disease

A study testing Ground beef in people with Lipoprotein Metabolism Disorder, run by Texas A&M University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 23 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for
Lipoprotein Metabolism Disorder
What is being tested?
Ground beef
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
No sites listed yet
Study dates
27 Mar 2006to 31 May 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 23 to 60 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Non-smoking

Who cannot join

  • Consuming restrictive diets, cholesterol-lowering medications

About this study

Official title: Manipulation of Beef Fatty Acids to Tailor Ground Beef Products to Individual Consumer Needs

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).

Read the 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.

Being tested
Ground beef
Keywords
ground beef, lipoprotein cholesterol, cardiovascular disease
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ground beefDietary supplement

    Ground beef naturally low in monounsaturated fatty acids or naturally high in monounsaturated fatty acids

Study groups in NCT04945980
Study groupRoleWhat they receive
Low-MUFA ground beefExperimentalParticipants consumed ground beef low in monounsaturated fatty acids.
Receives: Dietary Supplement: Ground beef
High-MUFA ground beefExperimentalParticipants consumed ground beef high in monounsaturated fatty acids.
Receives: Dietary Supplement: Ground beef

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lipoprotein cholesterol

    Plasma very low-density, low-density, and high-density cholesterol concentrations

    Measured: 5 weeks

  2. Low-density lipoprotein particle size

    Plasma low-density lipoprotein particle size

    Measured: 5 weeks

Secondary outcomes (1)
  1. C-reactive protein

    Plasma C-reactive protein

    Measured: 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2021
  2. Study start27 Mar 2006
  3. Primary completion31 May 2006
  4. Study completion31 May 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
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
Single blind
Who is masked
Participant
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04945980
Sponsor's protocol ID
IRB2005-0435
Status last verified
Jun 2021
First submitted
25 Jun 2021
Last updated
30 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21525253

Questions about this trial

What is this clinical trial studying?

A study testing Ground beef in people with Lipoprotein Metabolism Disorder, run by Texas A&M University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lipoprotein cholesterol (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04945980, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.

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