Impact of Beef's Unique Food Matrix on Human Health

NCT04841460 | Completed

• 1 other identifier: IRB2018-0755D
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of the proposed research is to document changes in plasma lipoprotein fractions, including high-density lipoprotein (HDL) and low-density lipoprotein (LDL) particle sizes and functionality, following the ground beef interventions. This specifically addresses the hypothesis that increasing the amount of fat in ground beef reduces risk factors for cardiovascular disease. Also, the investigators will measure changes in glucose, insulin, and triacylglycerols (TAG) following low-fat and high-fat ground beef interventions. An important aspect of this research is that the investigators will confirm that consumption of high-fat ground beef will reduce carbohydrate intake and increase insulin sensitivity in men. Furthermore, the investigators will be able to establish which protein sources are voluntarily replaced by the low- and high-fat ground beefs.

Conditions

Cholesterol, LDL; Cholesterol, HDL; Research Subjects

Outcome Measures

Primary Outcomes (1)

• Lipoprotein cholesterol

  Lipoprotein cholesterol concentrations and density distributions

  10 weeks

Secondary Outcomes (2)

• Dietary intake

  10 weeks

• Body mass index

  10 weeks

Study Arms (2)

Low-fat ground beef

EXPERIMENTAL

Participants will consume 25 low-fat ground beef patties, 5 patties per week for 5 weeks.

Dietary Supplement: Low-fat ground beef

High-fat ground beef

EXPERIMENTAL

Participants will consume 25 high-fat ground beef patties, 5 patties per week for 5 weeks.

Dietary Supplement: High-fat ground beef

Interventions

Low-fat ground beef DIETARY_SUPPLEMENT

5% fat ground beef

Low-fat ground beef

High-fat ground beef DIETARY_SUPPLEMENT

25% fat ground beef

High-fat ground beef

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The participants will be male and not have had total cholesterol above 300 mg/dL or below 120 mg/dL.

You may not qualify if:

• The participants will be male and must not have been consuming restrictive diets or cholesterol-lowering medications.

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M University

College Station, Texas, 77843, United States

Location

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.

  PMID: 21525253 RESULT

Study Officials

• Stephen B. Smith, Ph.D.

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participant identities were coded and treatments were blinded.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study design is a two-period, randomized crossover design.

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: April 12, 2021
• Study Start: February 18, 2019
• Primary Completion: July 19, 2019
• Study Completion: September 30, 2019
• Last Updated: April 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)