Food First Approach to Stimulate Muscle Protein Synthesis in Healthy Adults (Salmon)

September 24, 2020 updated by: Nicholas Burd, University of Illinois at Urbana-Champaign
In a crossover design 10 young healthy adults (20-35 y) will receive stable isotope tracer infusions and perform a single bout of resistance exercise. Immediately after exercise participants will ingest either 3.5 oz of Salmon fillet or its constituent macronutrients as isolated amino acids and fat. Repeated blood and breath samples as well as muscle biopsies will be collected to determine whole body amino acid kinetics, muscle amino acid transporters, anabolic signalling and myofibrillar protein synthesis rates during the trials

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

On both infusion trials, participants will report to the laboratory at 0700 h after an overnight fast. Upon arrival to the lab, the participant will fill out a questionnaire and a baseline breath sample will be collected to determine 13CO2 enrichment by isotope ratio mass spectrometry. A Teflon catheter will be inserted into the antecubital vein for a baseline blood sample (t=-210) and then participants will receive priming doses of NaH13CO2 (2.35 µmol·kg-1), L-[1-13C]leucine (7.6 µmol·kg-1), and L-[ring-2H5]phenylalanine (2.0 µmol·kg-1). Subsequently, a continuous intravenous solution of L-[1-13C]leucine (0.10 µmol·kg-1·min-1) and L-[ring-2H5]phenylalanine (0.05 µmol·kg-1·min-1) will be initiated (t=-210) and maintained over the infusion trials. A second Teflon catheter will be inserted into a heated dorsal vein for repeated arterialized blood sampling and remained patent by a 0.9% saline drip. Breath samples and arterialized blood samples will be collected every 30 to 60 minutes during the postabsorptive and postprandial states. In the post-absorptive state of infusion trial 1, muscle biopsies will be collected at t=-150 and -30 min of infusion to determine basal-state myofibrillar protein synthesis rates, relative skeletal muscle amino acid transporter content, and anabolic-related signaling. In the subsequent cross-over trial only 1 muscle biopsy will be collected at t=-30 for Western blot analysis and postabsorptive myofibrillar protein-bound tracer enrichment. After collection of the resting muscle biopsy at t=-30 for both trials, the participants will perform resistance exercise that consists of 4 sets of 10-12 repetitions or to muscular failure at 65-70% of 1-RM for both leg press and leg extension exercise.

Immediately after the completion of the exercise bout, participants will ingest either 3.5 oz of Salmon fillet or a matched isolated amino acid and fat mixture (t=0). Completion of the meal will mark the start of the postprandial stage and additional muscle biopsies will be collected at t=120 and t=300.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Freer Hall

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 20-35 years
  • Recreationally-active adults: ≥ 30 min of physical activity at moderate intensity ≥ 3 times per week
  • English fluency

Exclusion Criteria:

  • Smoking
  • Known allergies to fish consumption
  • Vegans
  • Diagnosed GI tract diseases
  • Arthritic conditions
  • A history of neuromuscular problems
  • Diagnosed cognitive impairments
  • Recent (1 year) participation in amino acid tracer studies
  • Predisposition to hypertrophic scarring or keloid formation
  • Individuals on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications).
  • High blood pressure (Systolic > 140 mm HG; Diastolic > 90 mm HG)
  • Alcohol consumption >10 drinks per week
  • Metabolic disorders (e.g., Metabolic Syndrome, diabetes, thyroid diseases)
  • Consumption of thyroid, androgenic or other medications known to affect endocrine function
  • Consumption of ergogenic-leves of dietary supplements that may affect muscle mass (e.g., creatine, HMB), insulin-like substances, or anabolic/catabolic pro-hormones (e.g., DHEA) within 6 weeks prior to participation
  • Currently pregnant
  • A suboptimal diet quality score as assessed by ASA24 dietary records
  • Asthma
  • Hypogonadism
  • Cardiovascular disease, arrhythmias

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Salmon
After resistance exercise, participants will ingest 3.5 oz of salmon fillet (21g protein, 24g fat) cooked sous-vide.
Behavioral: Resistance exercise
Participants will perform leg press and leg extension immediately prior to ingestion of salmon or isolated mixture
Other: Salmon
Participants will ingest salmon immediately after resistance exercise
Experimental: Isolated mixture
After resistance exercise, participants will ingest an isolated amino acid and fatty acid mixture matched to the amino acid and fatty acid content of 3.5 oz salmon fillet.
Behavioral: Resistance exercise
Participants will perform leg press and leg extension immediately prior to ingestion of salmon or isolated mixture
Dietary supplement: Isolated amino acids and fatty acids
Participants will ingest a mixture of isolated amino acids and fatty acids immediately after resistance exercise

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fractional synthetic rate of myofibrillar proteins
Time Frame: Postabsorptive for 3 hours, postprandial for 5 hours.
Myofibrillar protein synthesis rates will be assessed during the postabsorptive period for 3 hr and during the 5 hr after the ingestion of the experimental interventions. This will allow us to assess the change from the postabsorptive to the postprandial period.
Postabsorptive for 3 hours, postprandial for 5 hours.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Phosphorylation of muscle anabolic signaling
Time Frame: Baseline and at 2 and 5 hours after protein ingestion
Phosphorylation of anabolic signaling pathways will be assessed in the fasted state and at 2 and 5 hr after the ingestion of the experimental interventions.
Baseline and at 2 and 5 hours after protein ingestion
Exogenous rate of leucine appearance
Time Frame: 5 hour postprandial phase
Leucine oxidation rates will be assessed in the fasted state and at multiple time points in the postprandial phase.
5 hour postprandial phase

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Urbana-Champaign

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicholas A Burd, PhD, University of Illinois at Urbana-Champaign

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 22, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 22, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19293

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.

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