NCT04945980

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2006

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 27, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2006

Completed
15.1 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 30, 2021

Completed
Last Updated

June 30, 2021

Status Verified

June 1, 2021

Enrollment Period

2 months

First QC Date

June 25, 2021

Last Update Submit

June 25, 2021

Conditions

Keywords

ground beeflipoprotein cholesterolcardiovascular disease

Outcome Measures

Primary Outcomes (2)

  • Lipoprotein cholesterol

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

    5 weeks

  • Low-density lipoprotein particle size

    Plasma low-density lipoprotein particle size

    5 weeks

Secondary Outcomes (1)

  • C-reactive protein

    5 weeks

Study Arms (2)

Low-MUFA ground beef

EXPERIMENTAL

Participants consumed ground beef low in monounsaturated fatty acids.

Dietary Supplement: Ground beef

High-MUFA ground beef

EXPERIMENTAL

Participants consumed ground beef high in monounsaturated fatty acids.

Dietary Supplement: Ground beef

Interventions

Ground beefDIETARY_SUPPLEMENT

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

High-MUFA ground beefLow-MUFA ground beef

Eligibility Criteria

Age23 Years - 60 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMales
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Non-smoking

You may not qualify if:

  • Consuming restrictive diets, cholesterol-lowering medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Stephen Smith, Ph.D.

    Texas A&M University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were blinded to treatments.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2021

First Posted

June 30, 2021

Study Start

March 27, 2006

Primary Completion

May 31, 2006

Study Completion

May 31, 2006

Last Updated

June 30, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share