Trial Outcomes & Findings for Role of the Protein Matrix in the Anabolic Response to a Ground Beef Patty as Opposed to the Impossible (Vegi-) Burger (NCT NCT05197140)

NCT ID: NCT05197140

Last Updated: 2024-08-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

33 participants

Primary outcome timeframe

6 hours after consumption of intervention

Results posted on

2024-08-05

Participant Flow

Participant milestones

Participant milestones
Measure	4 Ounce Beef Patty Subjects consume one beef patty of 4 ounces of cooked meat. food: cooked 85% lean ground beef: see arm description	4 Ounce Vegetarian Burger Subjects consume one patty of 4 ounces of cooked vegetarian product. food: Impossible Burger (R): see arm description	2x 4 Ounce Vegetarian Burger Subjects consume two patties of 4 ounces of cooked vegetarian product. food: Impossible Burger (R): see arm description
Overall Study STARTED	11	11	11
Overall Study COMPLETED	8	8	8
Overall Study NOT COMPLETED	3	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	4 Ounce Beef Patty n=8 Participants Subjects consume one beef patty of 4 ounces of cooked meat. food: cooked 85% lean ground beef: see arm description	4 Ounce Vegetarian Burger n=8 Participants Subjects consume one patty of 4 ounces of cooked vegetarian product. food: Impossible Burger (R): see arm description	2x 4 Ounce Vegetarian Burger n=8 Participants Subjects consume two patties of 4 ounces of cooked vegetarian product. food: Impossible Burger (R): see arm description	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	24 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	30.0 years STANDARD_DEVIATION 7.4 • n=5 Participants	36.5 years STANDARD_DEVIATION 4.2 • n=7 Participants	28.9 years STANDARD_DEVIATION 5.8 • n=5 Participants	32.5 years STANDARD_DEVIATION 6.5 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	14 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	22 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants	24 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 hours after consumption of intervention

Outcome measures

Outcome measures
Measure	4 Ounce Beef Patty n=8 Participants Subjects consume one beef patty of 4 ounces of cooked meat. food: cooked 85% lean ground beef: see arm description	4 Ounce Vegetarian Burger n=8 Participants Subjects consume one patty of 4 ounces of cooked vegetarian product. food: Impossible Burger (R): see arm description	2x 4 Ounce Vegetarian Burger n=8 Participants Subjects consume two patties of 4 ounces of cooked vegetarian product. food: Impossible Burger (R): see arm description
Postprandial Plasma Essential Amino Acid Concentration Incremental Area-under-the-curve [ Time Frame: 360 Minutes]	117896 micromoles per liter per minute Standard Deviation 45787	75098 micromoles per liter per minute Standard Deviation 45231	94058 micromoles per liter per minute Standard Deviation 27252

Adverse Events

4 Ounce Beef Patty

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

4 Ounce Vegetarian Burger

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2x 4 Ounce Vegetarian Burger

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert Wolfe

University of Arkansas for Medical Sciences

Phone: 501-526-5769

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place