Protein MetabolismNCT05197140
Role of the Protein Matrix in the Anabolic Response to a Ground Beef Patty as Opposed to the Impossible (Vegi-) Burger
A study testing food: cooked 85% lean ground beef and food: Impossible Burger (R) in people with Protein Metabolism, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Protein Metabolism
- What is being tested?
- food: cooked 85% lean ground beef and food: Impossible Burger (R)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 3 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18 - 40 yrs.
- Body Mass Index of 20-32 inclusive
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Protein Metabolism
- Being tested
- food: cooked 85% lean ground beef, food: Impossible Burger (R)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
food: cooked 85% lean ground beefOther
Also called hamburger
see arm description
food: Impossible Burger (R)Other
Also called Impossible Burger (R)
see arm description
| Study group | Role | What they receive |
|---|---|---|
| 4 ounce beef patty | Active comparator | Subjects consume one beef patty of 4 ounces of cooked meat. Receives: Other: food: cooked 85% lean ground beef |
| 4 ounce vegetarian burger | Experimental | Subjects consume one patty of 4 ounces of cooked vegetarian product. Receives: Other: food: Impossible Burger (R) |
| 2x 4 ounce vegetarian burger | Experimental | Subjects consume two patties of 4 ounces of cooked vegetarian product. Receives: Other: food: Impossible Burger (R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 hours after consumption of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 May 2022
- Primary completion3 Nov 2022
- Study completion3 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Protein MetabolismStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197140
- Sponsor's protocol ID
- 273554
- Status last verified
- Mar 2023
- First submitted
- 15 Dec 2021
- Last updated
- 5 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39222687
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Protein Matrix in the Anabolic Response to a Ground Beef Patty as Opposed to the Impossible (Vegi-) Burger
- ClinicalTrials.gov ID
- NCT05197140
- Acronym / sponsor ID
- 273554
- Conditions
- Protein Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 3 Nov 2022 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Posted 5 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4 ounce beef patty | Active comparator | Other: food: cooked 85% lean ground beefSubjects consume one beef patty of 4 ounces of cooked meat. |
| 4 ounce vegetarian burger | Experimental | Other: food: Impossible Burger (R)Subjects consume one patty of 4 ounces of cooked vegetarian product. |
| 2x 4 ounce vegetarian burger | Experimental | Other: food: Impossible Burger (R)Subjects consume two patties of 4 ounces of cooked vegetarian product. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Ages 18 - 40 yrs.
- Body Mass Index of 20-32 inclusive
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| food: cooked 85% lean ground beefAlso: hamburgersee arm description | Other | 4 ounce beef patty |
| food: Impossible Burger (R)Also: Impossible Burger (R)see arm description | Other | 2x 4 ounce vegetarian burger, 4 ounce vegetarian burger |
Primary outcome
Postprandial Plasma Essential Amino Acid Concentration Incremental Area-under-the-curve [ Time Frame: 360 Minutes]
Time frame: 6 hours after consumption of intervention
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39222687Church 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing food: cooked 85% lean ground beef and food: Impossible Burger (R) in people with Protein Metabolism, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial Plasma Essential Amino Acid Concentration Incremental Area-under-the-curve [ Time Frame: 360 Minutes] (time frame: 6 hours after consumption of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05197140, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.