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Amino Acid Profile and Muscle Protein Synthetic Response to Consuming Meat or Plant-based Alternatives

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ClinicalTrials.gov Identifier: NCT04784806
Recruitment Status : Recruiting
First Posted : March 5, 2021
Last Update Posted : June 4, 2021
Sponsor:
Collaborator:
Rockefeller University
Information provided by (Responsible Party):
University of California, Davis

Brief 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).

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.


Condition or disease Intervention/treatment Phase
Healthy Other: Ground beef Other: Ground pork Other: Tofu Other: Beyond Meat Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Amino Acid Profile and Muscle Protein Synthetic Response to Consuming Meat or Plant-based Alternatives
Actual Study Start Date : April 30, 2021
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 30, 2021

Arm Intervention/treatment
Experimental: Consumption of ground beef
Consuming 106g of cooked ground beef (85% lean) to deliver 20g of protein.
Other: Ground beef
Subjects will consume a 106g patty of cooked ground beef.

Other: Ground pork
Subjects will consume a 118g patty of cooked ground pork

Other: Tofu
Subjects will consume a 113g patty of cooked tofu

Other: Beyond Meat
Subjects will consume a 113g BeyondMeat patty.

Experimental: Consumption of ground pork
Consuming 118g of cooked ground pork (72% lean) to deliver 20g of protein.
Other: Ground beef
Subjects will consume a 106g patty of cooked ground beef.

Other: Ground pork
Subjects will consume a 118g patty of cooked ground pork

Other: Tofu
Subjects will consume a 113g patty of cooked tofu

Other: Beyond Meat
Subjects will consume a 113g BeyondMeat patty.

Experimental: Consumption of tofu burger
Consuming 113g of cooked tofu to deliver 20g of protein.
Other: Ground beef
Subjects will consume a 106g patty of cooked ground beef.

Other: Ground pork
Subjects will consume a 118g patty of cooked ground pork

Other: Tofu
Subjects will consume a 113g patty of cooked tofu

Other: Beyond Meat
Subjects will consume a 113g BeyondMeat patty.

Experimental: Consumption of Beyond Meat burger
Consuming 113g of Beyond Meat burger to deliver 20g of protein.
Other: Ground beef
Subjects will consume a 106g patty of cooked ground beef.

Other: Ground pork
Subjects will consume a 118g patty of cooked ground pork

Other: Tofu
Subjects will consume a 113g patty of cooked tofu

Other: Beyond Meat
Subjects will consume a 113g BeyondMeat patty.




Primary Outcome Measures :
  1. 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.


  2. 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.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04784806


Contacts
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Contact: Karine Schaal, ph.D. 530-219-2849 kschaal@ucdavis.edu
Contact: Keith Baar, Ph.D. 530-752-3367 kbaar@ucdavis.edu

Locations
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United States, California
CTSC Clinical Research Center Recruiting
Sacramento, California, United States, 95817
Contact: Christopher Kain, RN    916-734-5600    crkain@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Rockefeller University
Investigators
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Principal Investigator: Keith Baar, Ph.D. University of California, Davis
Publications:

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT04784806    
Other Study ID Numbers: 1548896
First Posted: March 5, 2021    Key Record Dates
Last Update Posted: June 4, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, Davis:
Meat protein
Plant protein
Muscle protein synthesis