HealthyNCT04784806
Amino Acid Profile and Muscle Protein Synthetic Response to Consuming Meat or Plant-based Alternatives
A study testing Ground beef, Ground pork and Tofu in people with Healthy, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of the study is to quantify and compare the serum amino acid profile, and muscle protein synthesis rates, in response to consuming isonitrogenous amounts of ground meat (beef and pork) or plant-based alternatives -(soy and pea protein-based patties). Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ground beef, Ground pork and Tofu
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2021to 23 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy active male (n=8) and female (n=8) volunteers aged 18 - 30 years
- normal weight (BMI between 18 and 25 kg/m2) will be recruited to participate in the study.
- To be considered active, volunteers must meet the following American College of Sports Medicine's guideline for physical activity for healthy adults: performing at least 150 minutes per week of moderate-to-vigorous intensity physical activity.
Who cannot join
- Health or dietary restriction that would be affected by the foods consumed.
- Known food allergy to legumes (soybeans, peas, peanuts) or meat (beef or pork)
- Anemia (low red blood cell count)
- Overweight or obesity (BMI > 25 kg/m2)
- Currently not meeting the ACSM physical activity recommendations (IPAQ score < 150 min/week of moderate-to-vigorous physical activity)
- Metabolic or endocrine disorder that would affect the digestion, absorption, and/or physiological response to any of the nutrients ingested
Show all 11Show fewer
- Receiving any medication that may interfere with the study
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
CTSC Clinical Research Center
Sacramento, California, 95817
About this study
The purpose of the study is to quantify and compare the serum amino acid profile, and muscle protein synthesis rates, in response to consuming isonitrogenous amounts of ground meat (beef and pork) or plant-based alternatives -(soy and pea protein-based patties).
Specific aim 1: Describe the post-prandial amino acid profile in serum in the 3 hours following consumption of the following four burger patties, in quantities calculated to deliver 20 grams of protein: ground beef, ground pork, Beyond Meat® burger, and tofu burger.
Specific aim 2: Compare the ability of these four different foods to activate mTORC1 and protein synthesis in muscle.
Read the detailed description
Study design:
The first visit will be a brief meeting conducted over Zoom with one of the investigators (Karine Schaal), who will go over the study details with the volunteer, answer their questions, and obtain informed consent. Subjects will sign the informed consent electronically, using DocuSign. Subjects will be given a copy of their signed informed consent form. A paper copy of the consent form will be kept in a locked file cabinet in the office of the principal investigator.
Study volunteers will come to the CTSC Clinical Research Center (CCRC) on four separate occasions. The CCRC is located in the Cypress Building adjacent to the UC Davis Medical Center (2221 Stockton Blvd, Suite D, Sacramento CA 95817).
The four study visits will be test visits scheduled over a two week period (i.e. twice per week for 2 weeks), at the same time in the morning following and overnight (> 12 hour) fast. They will be asked to refrain from vigorous exercise, caffeine, nicotine and alcohol for 24 hours prior to each visit. Female volunteers will be asked to schedule their study visits within the first two weeks of their menstrual cycle (starting on the first day of menstrual bleeding), in order to control for ovarian hormone fluctuations which may impact digestion and metabolism.
Upon arrival to the CCRC on the first test visit, each volunteer's height and weight will be measured.
- Baseline blood draw. Subjects will then be placed in individual testing rooms, equipped with a reclining phlebotomy armchair. A registered nurse or nurse practitioner will insert a 22G catheter in a forearm vein and an initial 3.5 mL baseline blood sample will be collected.
II. Test meal.
After the baseline blood sample is collected, subjects will consume one of the following four burgers in isonitrogenous amounts to deliver 20 g of protein:
- 106g ground beef patty (85% lean + 15% fat)
- 118g ground pork (72.5% lean + 27.5% fat)
- 113g Beyond Meat® patty
- 113g tofu patty
Each food will be weighed before cooking. The beef, pork and Beyond® burgers will be grilled on an indoor electric grill until internal temperature reaches 165°F to comply with the USDA Recommendations for Food Safety (beef and pork, minimum 160°F) and manufacturer instructions (Beyond Meat®). Tofu burgers are pre-cooked and will be warmed by grilling for 2 minutes, per manufacturer recommendations. The internal temperature of the burgers will be monitored using a meat thermometer. The burgers will be served to the volunteers as soon as they are finished cooking.
Subjects will be asked to consume each patty without buns or condiments within a 10 minute period, and instructed to chew thoroughly. They will also be asked to drink a 6 ounce glass of water with the meal.
III. Postprandial blood draws.
Following consumption of the test meal, the participants will remain at the research site, in their individual testing room, for another 3 hours, sitting quietly - they may bring books or electronic devices to pass the time. Five more blood samples of 3.5 mL each will be obtained at 30, 60, 90, 120 and 180 minutes after the test meal, totaling six blood draws of 3.5mL per visit (21mL per visit), and 84 mL of blood drawn in total for each subject completing the entire study.
Blood will be collected in 3.5 mL serum separating tubes. Approximately 50 microliters of whole-blood will be used to measure blood glucose within 5 minutes of the draw. The rest will be allowed to clot for 1hr before centrifugation at 1000 x g for 10 minutes.The serum will be frozen and kept at -80°C until processed. 100 microliters of each serum sample will be used for determining amino acid concentrations by high performance liquid chromatography (HPLC) at the UC Davis Proteomics Core. Another 100 microliters will be used to measure insulin concentrations via enzyme-linked immunoassay. The rest of the serum will be used for developing the mTORC1 bioassay.
The order in which subjects receive each test meal will be randomized to avoid any order effect, and at least a two-day washout period will be given between visits.
- Conditions
- Healthy
- Being tested
- Ground beef, Ground pork, Tofu, Beyond Meat
- Keywords
- Meat protein, Plant protein, Muscle protein synthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ground beefOther
Subjects will consume a 106g patty of cooked ground beef.
Ground porkOther
Subjects will consume a 118g patty of cooked ground pork
TofuOther
Subjects will consume a 113g patty of cooked tofu
Beyond MeatOther
Subjects will consume a 113g BeyondMeat patty.
| Study group | Role | What they receive |
|---|---|---|
| Consumption of ground beef | Experimental | Consuming 106g of cooked ground beef (85% lean) to deliver 20g of protein. Receives: Other: Ground beef; Other: Ground pork; Other: Tofu; Other: Beyond Meat |
| Consumption of ground pork | Experimental | Consuming 118g of cooked ground pork (72% lean) to deliver 20g of protein. Receives: Other: Ground beef; Other: Ground pork; Other: Tofu; Other: Beyond Meat |
| Consumption of tofu burger | Experimental | Consuming 113g of cooked tofu to deliver 20g of protein. Receives: Other: Ground beef; Other: Ground pork; Other: Tofu; Other: Beyond Meat |
| Consumption of Beyond Meat burger | Experimental | Consuming 113g of Beyond Meat burger to deliver 20g of protein. Receives: Other: Ground beef; Other: Ground pork; Other: Tofu; Other: Beyond Meat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of serum amino acid concentrations after consuming each test meal.
A fasted 3.5mL baseline blood sample will be collected in serum separating tubes, after which subjects will consume one of the four patties. Five 3.5mL blood samples will be obtained at 30, 60, 90, 120 and 180 minutes following the patty consumption.
Blood will be allowed to clot for 1hr before centrifugation at 1000 x g for 10 minutes. The serum will be frozen and kept at -80°C until processed. 100 microliters of each serum sample will be used for determining amino acid concentrations by high performance liquid chromatography (HPLC) at the UC Davis Proteomics Core.
Measured: Baseline and 30, 60, 90, 120 and 180 minutes after consuming each test meal
Quantification of muscle protein synthesis rates in vitro
The rest of the serum obtained from the procedures described in Outcome 1 will be used for developing the mTORC1 bioassay and quantify the rate of muscle protein synthesis in vitro.
Measured: Baseline and 30, 60, 90, 120 and 180 minutes after consuming each test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start30 Apr 2021
- Primary completion23 Sep 2021
- Study completion23 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Rockefeller University
- Responsible party
- Sponsor
- Investigators
- Keith Baar, Ph.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784806
- Sponsor's protocol ID
- 1548896
- Status last verified
- Jan 2022
- First submitted
- 3 Mar 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tang JE, Moore DR, Kujbida GW, Tarnopolsky MA, Phillips SM. Ingestion of whey hydrolysate, casein, or soy protein isolate: effects on mixed muscle protein synthesis at rest and following resistance exercise in young men. J Appl Physiol (1985). 2009 Sep;107(3):987-92. doi: 10.1152/japplphysiol.00076.2009. Epub 2009 Jul 9.
PubMed 19589961Dickinson JM, Fry CS, Drummond MJ, Gundermann DM, Walker DK, Glynn EL, Timmerman KL, Dhanani S, Volpi E, Rasmussen BB. Mammalian target of rapamycin complex 1 activation is required for the stimulation of human skeletal muscle protein synthesis by essential amino acids. J Nutr. 2011 May;141(5):856-62. doi: 10.3945/jn.111.139485. Epub 2011 Mar 23.
PubMed 21430254Baar K, Esser K. Phosphorylation of p70(S6k) correlates with increased skeletal muscle mass following resistance exercise. Am J Physiol. 1999 Jan;276(1):C120-7. doi: 10.1152/ajpcell.1999.276.1.C120.
PubMed 9886927Witard OC, McGlory C, Hamilton DL, Phillips SM. Growing older with health and vitality: a nexus of physical activity, exercise and nutrition. Biogerontology. 2016 Jun;17(3):529-46. doi: 10.1007/s10522-016-9637-9. Epub 2016 Feb 15.
PubMed 26878863Wolfson RL, Sabatini DM. The Dawn of the Age of Amino Acid Sensors for the mTORC1 Pathway. Cell Metab. 2017 Aug 1;26(2):301-309. doi: 10.1016/j.cmet.2017.07.001.
PubMed 28768171van Vliet S, Burd NA, van Loon LJ. The Skeletal Muscle Anabolic Response to Plant- versus Animal-Based Protein Consumption. J Nutr. 2015 Sep;145(9):1981-91. doi: 10.3945/jn.114.204305. Epub 2015 Jul 29.
PubMed 26224750Tipton KD, Ferrando AA, Phillips SM, Doyle D Jr, Wolfe RR. Postexercise net protein synthesis in human muscle from orally administered amino acids. Am J Physiol. 1999 Apr;276(4):E628-34. doi: 10.1152/ajpendo.1999.276.4.E628.
PubMed 10198297
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amino Acid Profile and Muscle Protein Synthetic Response to Consuming Meat or Plant-based Alternatives
- ClinicalTrials.gov ID
- NCT04784806
- Acronym / sponsor ID
- 1548896
- Conditions
- Healthy
- Keywords
- Meat protein, Plant protein, Muscle protein synthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Rockefeller University
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to quantify and compare the serum amino acid profile, and muscle protein synthesis rates, in response to consuming isonitrogenous amounts of ground meat (beef and pork) or plant-based alternatives -(soy and pea protein-based patties).
Specific aim 1: Describe the post-prandial amino acid profile in serum in the 3 hours following consumption of the following four burger patties, in quantities calculated to deliver 20 grams of protein: ground beef, ground pork, Beyond Meat® burger, and tofu burger.
Specific aim 2: Compare the ability of these four different foods to activate mTORC1 and protein synthesis in muscle.
Detailed description
Study design:
The first visit will be a brief meeting conducted over Zoom with one of the investigators (Karine Schaal), who will go over the study details with the volunteer, answer their questions, and obtain informed consent. Subjects will sign the informed consent electronically, using DocuSign. Subjects will be given a copy of their signed informed consent form. A paper copy of the consent form will be kept in a locked file cabinet in the office of the principal investigator.
Study volunteers will come to the CTSC Clinical Research Center (CCRC) on four separate occasions. The CCRC is located in the Cypress Building adjacent to the UC Davis Medical Center (2221 Stockton Blvd, Suite D, Sacramento CA 95817).
The four study visits will be test visits scheduled over a two week period (i.e. twice per week for 2 weeks), at the same time in the morning following and overnight (> 12 hour) fast. They will be asked to refrain from vigorous exercise, caffeine, nicotine and alcohol for 24 hours prior to each visit. Female volunteers will be asked to schedule their study visits within the first two weeks of their menstrual cycle (starting on the first day of menstrual bleeding), in order to control for ovarian hormone fluctuations which may impact digestion and metabolism.
Upon arrival to the CCRC on the first test visit, each volunteer's height and weight will be measured.
- Baseline blood draw. Subjects will then be placed in individual testing rooms, equipped with a reclining phlebotomy armchair. A registered nurse or nurse practitioner will insert a 22G catheter in a forearm vein and an initial 3.5 mL baseline blood sample will be collected.
II. Test meal.
After the baseline blood sample is collected, subjects will consume one of the following four burgers in isonitrogenous amounts to deliver 20 g of protein:
- 106g ground beef patty (85% lean + 15% fat)
- 118g ground pork (72.5% lean + 27.5% fat)
- 113g Beyond Meat® patty
- 113g tofu patty
Each food will be weighed before cooking. The beef, pork and Beyond® burgers will be grilled on an indoor electric grill until internal temperature reaches 165°F to comply with the USDA Recommendations for Food Safety (beef and pork, minimum 160°F) and manufacturer instructions (Beyond Meat®). Tofu burgers are pre-cooked and will be warmed by grilling for 2 minutes, per manufacturer recommendations. The internal temperature of the burgers will be monitored using a meat thermometer. The burgers will be served to the volunteers as soon as they are finished cooking.
Subjects will be asked to consume each patty without buns or condiments within a 10 minute period, and instructed to chew thoroughly. They will also be asked to drink a 6 ounce glass of water with the meal.
III. Postprandial blood draws.
Following consumption of the test meal, the participants will remain at the research site, in their individual testing room, for another 3 hours, sitting quietly - they may bring books or electronic devices to pass the time. Five more blood samples of 3.5 mL each will be obtained at 30, 60, 90, 120 and 180 minutes after the test meal, totaling six blood draws of 3.5mL per visit (21mL per visit), and 84 mL of blood drawn in total for each subject completing the entire study.
Blood will be collected in 3.5 mL serum separating tubes. Approximately 50 microliters of whole-blood will be used to measure blood glucose within 5 minutes of the draw. The rest will be allowed to clot for 1hr before centrifugation at 1000 x g for 10 minutes.The serum will be frozen and kept at -80°C until processed. 100 microliters of each serum sample will be used for determining amino acid concentrations by high performance liquid chromatography (HPLC) at the UC Davis Proteomics Core. Another 100 microliters will be used to measure insulin concentrations via enzyme-linked immunoassay. The rest of the serum will be used for developing the mTORC1 bioassay.
The order in which subjects receive each test meal will be randomized to avoid any order effect, and at least a two-day washout period will be given between visits.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Consumption of ground beef | Experimental | Other: Ground beef, Other: Ground pork, Other: Tofu, Other: Beyond MeatConsuming 106g of cooked ground beef (85% lean) to deliver 20g of protein. |
| Consumption of ground pork | Experimental | Other: Ground beef, Other: Ground pork, Other: Tofu, Other: Beyond MeatConsuming 118g of cooked ground pork (72% lean) to deliver 20g of protein. |
| Consumption of tofu burger | Experimental | Other: Ground beef, Other: Ground pork, Other: Tofu, Other: Beyond MeatConsuming 113g of cooked tofu to deliver 20g of protein. |
| Consumption of Beyond Meat burger | Experimental | Other: Ground beef, Other: Ground pork, Other: Tofu, Other: Beyond MeatConsuming 113g of Beyond Meat burger to deliver 20g of protein. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy active male (n=8) and female (n=8) volunteers aged 18 - 30 years
- normal weight (BMI between 18 and 25 kg/m2) will be recruited to participate in the study.
- To be considered active, volunteers must meet the following American College of Sports Medicine's guideline for physical activity for healthy adults: performing at least 150 minutes per week of moderate-to-vigorous intensity physical activity.
Key exclusion criteria (11 listed)
- Health or dietary restriction that would be affected by the foods consumed.
- Known food allergy to legumes (soybeans, peas, peanuts) or meat (beef or pork)
- Anemia (low red blood cell count)
- Overweight or obesity (BMI > 25 kg/m2)
- Currently not meeting the ACSM physical activity recommendations (IPAQ score < 150 min/week of moderate-to-vigorous physical activity)
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 |
|---|---|---|
| Ground beefSubjects will consume a 106g patty of cooked ground beef. | Other | Consumption of Beyond Meat burger, Consumption of ground beef, Consumption of ground pork, Consumption of tofu burger |
| Ground porkSubjects will consume a 118g patty of cooked ground pork | Other | Consumption of Beyond Meat burger, Consumption of ground beef, Consumption of ground pork, Consumption of tofu burger |
| TofuSubjects will consume a 113g patty of cooked tofu | Other | Consumption of Beyond Meat burger, Consumption of ground beef, Consumption of ground pork, Consumption of tofu burger |
| Beyond MeatSubjects will consume a 113g BeyondMeat patty. | Other | Consumption of Beyond Meat burger, Consumption of ground beef, Consumption of ground pork, Consumption of tofu burger |
Primary outcome
Quantification of serum amino acid concentrations after consuming each test meal.
Time frame: Baseline and 30, 60, 90, 120 and 180 minutes after consuming each test meal
A fasted 3.5mL baseline blood sample will be collected in serum separating tubes, after which subjects will consume one of the four patties. Five 3.5mL blood samples will be obtained at 30, 60, 90, 120 and 180 minutes following the patty consumption. Blood will be allowed to clot for 1hr before centrifugation at 1000 x g for 10 minutes. The serum will be frozen and kept at -80°C until processed. 100 microliters of each serum sample will be used for determining amino acid concentrations by high performance liquid chromatography (HPLC) at the UC Davis Proteomics Core.
Quantification of muscle protein synthesis rates in vitro
Time frame: Baseline and 30, 60, 90, 120 and 180 minutes after consuming each test meal
The rest of the serum obtained from the procedures described in Outcome 1 will be used for developing the mTORC1 bioassay and quantify the rate of muscle protein synthesis in vitro.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Background: PubMed 19589961Tang JE, Moore DR, Kujbida GW, Tarnopolsky MA, Phillips SM. Ingestion of whey hydrolysate, casein, or soy protein isolate: effects on mixed muscle protein synthesis at rest and following resistance exercise in young men. J Appl Physiol (1985). 2009 Sep;107(3):987-92. doi: 10.1152/japplphysiol.00076.2009. Epub 2009 Jul 9.
- Background: PubMed 21430254Dickinson JM, Fry CS, Drummond MJ, Gundermann DM, Walker DK, Glynn EL, Timmerman KL, Dhanani S, Volpi E, Rasmussen BB. Mammalian target of rapamycin complex 1 activation is required for the stimulation of human skeletal muscle protein synthesis by essential amino acids. J Nutr. 2011 May;141(5):856-62. doi: 10.3945/jn.111.139485. Epub 2011 Mar 23.
- Background: PubMed 9886927Baar K, Esser K. Phosphorylation of p70(S6k) correlates with increased skeletal muscle mass following resistance exercise. Am J Physiol. 1999 Jan;276(1):C120-7. doi: 10.1152/ajpcell.1999.276.1.C120.
- Background: PubMed 26878863Witard OC, McGlory C, Hamilton DL, Phillips SM. Growing older with health and vitality: a nexus of physical activity, exercise and nutrition. Biogerontology. 2016 Jun;17(3):529-46. doi: 10.1007/s10522-016-9637-9. Epub 2016 Feb 15.
- Background: PubMed 28768171Wolfson RL, Sabatini DM. The Dawn of the Age of Amino Acid Sensors for the mTORC1 Pathway. Cell Metab. 2017 Aug 1;26(2):301-309. doi: 10.1016/j.cmet.2017.07.001.
- Background: PubMed 26224750van Vliet S, Burd NA, van Loon LJ. The Skeletal Muscle Anabolic Response to Plant- versus Animal-Based Protein Consumption. J Nutr. 2015 Sep;145(9):1981-91. doi: 10.3945/jn.114.204305. Epub 2015 Jul 29.
- Background: PubMed 10198297Tipton KD, Ferrando AA, Phillips SM, Doyle D Jr, Wolfe RR. Postexercise net protein synthesis in human muscle from orally administered amino acids. Am J Physiol. 1999 Apr;276(4):E628-34. doi: 10.1152/ajpendo.1999.276.4.E628.
- Learn more or sign up for the study here!Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Keith Baar, Ph.D. principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ground beef, Ground pork and Tofu in people with Healthy, run by University of California, Davis 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 3 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 14 Jan 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quantification of serum amino acid concentrations after consuming each test meal. (time frame: Baseline and 30, 60, 90, 120 and 180 minutes after consuming each test meal). The study lists 2 primary outcomes in all. 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 NCT04784806, which also lists 7 linked publications.
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 14 Jan 2022.