- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05197140
Role of the Protein Matrix in the Anabolic Response to a Ground Beef Patty as Opposed to the Impossible (Vegi-) Burger
March 27, 2023 updated by: University of Arkansas
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- UAMS Center on Aging
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 4 ounce beef patty
Subjects consume one beef patty of 4 ounces of cooked meat.
|
see arm description
Other Names:
|
Experimental: 4 ounce vegetarian burger
Subjects consume one patty of 4 ounces of cooked vegetarian product.
|
see arm description
Other Names:
|
Experimental: 2x 4 ounce vegetarian burger
Subjects consume two patties of 4 ounces of cooked vegetarian product.
|
see arm description
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma amino acid concentrations (area under the curve after consumption of intervention/s)
Time Frame: 6 hours after consumption of intervention
|
6 hours after consumption of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2022
Primary Completion (Actual)
November 3, 2022
Study Completion (Actual)
November 3, 2022
Study Registration Dates
First Submitted
December 15, 2021
First Submitted That Met QC Criteria
January 4, 2022
First Posted (Actual)
January 19, 2022
Study Record Updates
Last Update Posted (Actual)
March 28, 2023
Last Update Submitted That Met QC Criteria
March 27, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 273554
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Protein Metabolism
-
University of Illinois at Urbana-ChampaignCompletedMuscle Protein Synthesis | Protein MetabolismUnited States
-
University of ArkansasCompletedProtein | MetabolismUnited States
-
University of ArkansasCompletedProtein MetabolismUnited States
-
University of ArkansasCompletedProtein MetabolismUnited States
-
University of Illinois at Urbana-ChampaignBIO-CAT, Inc.CompletedProtein MetabolismUnited States
-
University of Illinois at Urbana-ChampaignCompletedProtein MetabolismUnited States
-
University of AarhusInnovation Fund Denmark; Arla Foods; Team DenmarkCompletedProtein Metabolism
-
Texas A&M UniversityRecruiting
-
Texas A&M UniversityUnknownProtein MetabolismUnited States
-
Maastricht University Medical CenterDSM Food SpecialtiesRecruitingProtein Metabolism DisorderNetherlands
Clinical Trials on food: cooked 85% lean ground beef
-
University of ArkansasCompleted
-
University of GuelphOntario Bean GrowersCompleted