NCT04784806

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 30, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2021

Completed
Last Updated

January 14, 2022

Status Verified

January 1, 2022

Enrollment Period

5 months

First QC Date

March 3, 2021

Last Update Submit

January 13, 2022

Conditions

Keywords

Meat proteinPlant proteinMuscle protein synthesis

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline and 30, 60, 90, 120 and 180 minutes after consuming each test meal

Study Arms (4)

Consumption of ground beef

EXPERIMENTAL

Consuming 106g of cooked ground beef (85% lean) to deliver 20g of protein.

Other: Ground beefOther: Ground porkOther: TofuOther: Beyond Meat

Consumption of ground pork

EXPERIMENTAL

Consuming 118g of cooked ground pork (72% lean) to deliver 20g of protein.

Other: Ground beefOther: Ground porkOther: TofuOther: Beyond Meat

Consumption of tofu burger

EXPERIMENTAL

Consuming 113g of cooked tofu to deliver 20g of protein.

Other: Ground beefOther: Ground porkOther: TofuOther: Beyond Meat

Consumption of Beyond Meat burger

EXPERIMENTAL

Consuming 113g of Beyond Meat burger to deliver 20g of protein.

Other: Ground beefOther: Ground porkOther: TofuOther: Beyond Meat

Interventions

Subjects will consume a 106g patty of cooked ground beef.

Consumption of Beyond Meat burgerConsumption of ground beefConsumption of ground porkConsumption of tofu burger

Subjects will consume a 118g patty of cooked ground pork

Consumption of Beyond Meat burgerConsumption of ground beefConsumption of ground porkConsumption of tofu burger
TofuOTHER

Subjects will consume a 113g patty of cooked tofu

Consumption of Beyond Meat burgerConsumption of ground beefConsumption of ground porkConsumption of tofu burger

Subjects will consume a 113g BeyondMeat patty.

Consumption of Beyond Meat burgerConsumption of ground beefConsumption of ground porkConsumption of tofu burger

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CTSC Clinical Research Center

Sacramento, California, 95817, United States

Location

Related Publications (7)

  • 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.

    PMID: 19589961BACKGROUND
  • Dickinson 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.

    PMID: 21430254BACKGROUND
  • Baar 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.

    PMID: 9886927BACKGROUND
  • Witard 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.

    PMID: 26878863BACKGROUND
  • Wolfson 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.

    PMID: 28768171BACKGROUND
  • van 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.

    PMID: 26224750BACKGROUND
  • Tipton 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.

    PMID: 10198297BACKGROUND

Related Links

MeSH Terms

Interventions

Soy Foods

Intervention Hierarchy (Ancestors)

Fermented FoodsDiet, Food, and NutritionPhysiological PhenomenaVegetable ProductsVegetablesFoodFood and Beverages

Study Officials

  • Keith Baar, Ph.D.

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2021

First Posted

March 5, 2021

Study Start

April 30, 2021

Primary Completion

September 23, 2021

Study Completion

September 23, 2021

Last Updated

January 14, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations