Role of the Protein Matrix in the Anabolic Response to a Ground Beef Patty as Opposed to the Impossible (Vegi-) Burger

NCT05197140 | Completed Results

• 1 other identifier: 273554
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Several of the investigator's recent studies have shown that all dietary proteins are not equal when it comes to making proteins in human bodies. Generally, foods made from animal muscle tissue are much more efficient at making new proteins in the body that those from plant sources. This study will measure the amount of protein growth in participants after consuming either one beef patty, one vegi-burger, or two vegi-burgers. By using stable isotope infusions and collecting blood and leg muscle samples, the investigator's lab can determine the rate of muscle metabolism that happens after a participant eats a protein-containing food. The investigator wants to determine if the vegi-burger is as efficient as the beef patty at creating proteins in a participants. The investigator will measure this metabolism over a 10-hour period, with the food being eaten at the 4 hour mark. The investigator plans to perform this procedure on up to 8 participants per food option (24 total).

Conditions

Protein Metabolism

Outcome Measures

Primary Outcomes (1)

• Postprandial Plasma Essential Amino Acid Concentration Incremental Area-under-the-curve [ Time Frame: 360 Minutes]

  Free leucine, isoleucine, valine, histidine, lysine, methionine, phenylalanine, threonine, tryptophan (combined) (µmol·L\^(-1)·min). Following time points (in minutes) post-ingestion will be used to calculate the incremental area under the curve: 60, 90, 120, 180, 210, 240, 270, 300, 330, 360.

  6 hours after consumption of intervention

Study Arms (3)

4 ounce beef patty

ACTIVE COMPARATOR

Subjects consume one beef patty of 4 ounces of cooked meat.

Other: food: cooked 85% lean ground beef

4 ounce vegetarian burger

EXPERIMENTAL

Subjects consume one patty of 4 ounces of cooked vegetarian product.

Other: food: Impossible Burger (R)

2x 4 ounce vegetarian burger

EXPERIMENTAL

Subjects consume two patties of 4 ounces of cooked vegetarian product.

Other: food: Impossible Burger (R)

Interventions

food: cooked 85% lean ground beef OTHER

see arm description

Also known as: hamburger

4 ounce beef patty

food: Impossible Burger (R) OTHER

see arm description

Also known as: Impossible Burger (R)

2x 4 ounce vegetarian burger; 4 ounce vegetarian burger

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 18 - 40 yrs.
• Body Mass Index of 20-32 inclusive

You may not qualify if:

• Unwilling to eat animal proteins
• History of diabetes that requires medication for control of blood glucose
• History of malignancy or chemo/radiation therapy in the 6 months prior to enrollment
• History of gastrointestinal bypass/reduction surgery (Lapband, gastric sleeve, etc.)
• Pregnant females
• Hemoglobin less than 12 g/dL at screening
• Platelets less than 150,000 at screening
• Subjects who cannot refrain from using protein or amino acid supplements for 7 days prior to Visit 3
• Concomitant use of oral or injectable corticosteroids
• Concomitant use of testosterone, IGF-1, or similar anabolic agent
• Any other disease or condition that would place the subject at increased risk of harm if they were to participate, at the discretion of the study physician

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

UAMS Center on Aging

Little Rock, Arkansas, 72205, United States

Location

Related Publications (1)

• Church DD, Hirsch KR, Kviatkovsky SA, Matthews JJ, Ferrando AA, Azhar G, Wolfe RR. The anabolic response to a ground beef patty and soy-based meat alternative: a randomized controlled trial. Am J Clin Nutr. 2024 Nov;120(5):1085-1092. doi: 10.1016/j.ajcnut.2024.08.030. Epub 2024 Aug 31.

  PMID: 39222687 DERIVED

Results Point of Contact

• Title: Robert Wolfe
• Organization: University of Arkansas for Medical Sciences

rwolfe2@uams.edu

501-526-5769

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator will be blinded to group.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 19, 2022
• Study Start: May 1, 2022
• Primary Completion: November 3, 2022
• Study Completion: November 3, 2022
• Last Updated: August 5, 2024
• Results First Posted: August 5, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)