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

January 13, 2022 updated by: University of California, Davis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

I. 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 Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • CTSC Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 30, 60, 90, 120 and 180 minutes after consuming each test meal
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.
Baseline and 30, 60, 90, 120 and 180 minutes after consuming each test meal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

Rockefeller University

Investigators

  • Principal Investigator: Keith Baar, Ph.D., University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2021

Primary Completion (Actual)

September 23, 2021

Study Completion (Actual)

September 23, 2021

Study Registration Dates

First Submitted

March 3, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (Actual)

March 5, 2021

Study Record Updates

Last Update Posted (Actual)

January 14, 2022

Last Update Submitted That Met QC Criteria

January 13, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1548896

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Ground beef

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe