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

• Sponsor: University of Arkansas (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05197140
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 10
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Protein Metabolism	Other: food: cooked 85% lean ground beef; Other: food: Impossible Burger (R)	N/A

Detailed Description

According to the USDA Economic Research Service Food Availability Data, beef consumption has been on a general decline for the past 40 years, with current per capita consumption approximately 35% lower in 2020 than in 1980. Some of this decline over the past few years can be attributed to politically motivated claims that carbon emissions from cattle represent a major threat to the global environment. However, the major reason for declining beef consumption is the widely promulgated claim that beef is unhealthy. The hamburger in particular has become a poster child for the notion that beef consumption is responsible for the increasing occurrence of obesity in the United States. The trend of decreasing beef consumption due to perceived health concerns, particularly obesity and associated health problems, has led major fast-food chains such as Burger King and McDonalds, to offer vegetarian burgers as healthy alternatives to the traditional beef burger. However, examination of the components of the macronutrient matrix of a typical vegetarian burger gives reason to question the health benefits as compared to a traditional beef patty-hamburger.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Masking Description: Investigator will be blinded to group.
• Primary Purpose: Basic Science
• Official Title: Role of the Protein Matrix in the Anabolic Response to a Ground Beef Patty as Opposed to the Impossible (Vegi-) Burger
• Actual Study Start Date: May 1, 2022
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 4 ounce beef patty Subjects consume one beef patty of 4 ounces of cooked meat.	Other: food: cooked 85% lean ground beef; see arm description; Other Names: hamburger
Experimental: 4 ounce vegetarian burger Subjects consume one patty of 4 ounces of cooked vegetarian product.	Other: food: Impossible Burger (R); see arm description; Other Names: Impossible Burger (R)
Experimental: 2x 4 ounce vegetarian burger Subjects consume two patties of 4 ounces of cooked vegetarian product.	Other: food: Impossible Burger (R); see arm description; Other Names: Impossible Burger (R)

Outcome Measures

Primary Outcome Measures

1. Plasma amino acid concentrations (area under the curve after consumption of intervention/s) [6 hours after consumption of intervention]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Ages 18 - 40 yrs.

• Body Mass Index of 20-32 inclusive

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAMS Center on Aging	Little Rock	Arkansas	United States	72205

Sponsors and Collaborators

• University of Arkansas

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Arkansas
• ClinicalTrials.gov Identifier: NCT05197140
• Other Study ID Numbers: 273554
• First Posted: Jan 19, 2022
• Last Update Posted: May 31, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 31, 2022