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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 ounce beef patty | Active Comparator | Subjects consume one beef patty of 4 ounces of cooked meat. |
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| 4 ounce vegetarian burger | Experimental | Subjects consume one patty of 4 ounces of cooked vegetarian product. |
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| 2x 4 ounce vegetarian burger | Experimental | Subjects consume two patties of 4 ounces of cooked vegetarian product. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| food: cooked 85% lean ground beef | Other | see arm description |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAMS Center on Aging | Little Rock | Arkansas | 72205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39222687 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 4 Ounce Beef Patty | Subjects consume one beef patty of 4 ounces of cooked meat. food: cooked 85% lean ground beef: see arm description |
| FG001 | 4 Ounce Vegetarian Burger | Subjects consume one patty of 4 ounces of cooked vegetarian product. food: Impossible Burger (R): see arm description |
| FG002 | 2x 4 Ounce Vegetarian Burger | Subjects consume two patties of 4 ounces of cooked vegetarian product. food: Impossible Burger (R): see arm description |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 4 Ounce Beef Patty | Subjects consume one beef patty of 4 ounces of cooked meat. food: cooked 85% lean ground beef: see arm description |
| BG001 | 4 Ounce Vegetarian Burger | Subjects consume one patty of 4 ounces of cooked vegetarian product. food: Impossible Burger (R): see arm description |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | micromoles per liter per minute | 6 hours after consumption of intervention |
|
Adverse events were collected over the duration of the study: total 6 months.
Definitions did not differ.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 4 Ounce Beef Patty | Subjects consume one beef patty of 4 ounces of cooked meat. food: cooked 85% lean ground beef: see arm description |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Wolfe | University of Arkansas for Medical Sciences | 501-526-5769 | rwolfe2@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 5, 2022 | Feb 26, 2024 | Prot_SAP_000.pdf |
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Investigator will be blinded to group.
| food: Impossible Burger (R) | Other | see arm description |
|
|
| BG002 | 2x 4 Ounce Vegetarian Burger | Subjects consume two patties of 4 ounces of cooked vegetarian product. food: Impossible Burger (R): see arm description |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Subjects consume one patty of 4 ounces of cooked vegetarian product.
food: Impossible Burger (R): see arm description
| OG002 | 2x 4 Ounce Vegetarian Burger | Subjects consume two patties of 4 ounces of cooked vegetarian product. food: Impossible Burger (R): see arm description |
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | 4 Ounce Vegetarian Burger | Subjects consume one patty of 4 ounces of cooked vegetarian product. food: Impossible Burger (R): see arm description | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | 2x 4 Ounce Vegetarian Burger | Subjects consume two patties of 4 ounces of cooked vegetarian product. food: Impossible Burger (R): see arm description | 0 | 8 | 0 | 8 | 0 | 8 |
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