NCT04969536

Brief Summary

The overall goal of this investigation was to determine the impact of branch-chained amino acids (BCAAs) supplementation on serotonin and associated metabolites during endurance exercise on healthy individuals. Specifically, despite the strong theoretical basis for supplementation of BCAAs to attenuate serotonin production and fatigue during exercise, most human clinical trials have failed to demonstrate these benefits. To shed light on this discrepancy, the purpose of this study was to measure the impact of BCAA supplementation on serotonin and associated metabolites during exercise. To achieve this purpose, investigators determined the effects of the consumption of a BCAA beverage on endurance exercise performance and serum metabolites. The supplementation protocol consisted of two trials in which each participant consumed 8 grams of BCAA supplement in a beverage or a placebo in randomized order. It was hypothesized that post-exercise metabolites would differ between BCAA and placebo conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable healthy

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

Study Start

First participant enrolled

October 1, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
Last Updated

May 3, 2023

Status Verified

July 1, 2021

Enrollment Period

1.4 years

First QC Date

July 9, 2021

Last Update Submit

May 1, 2023

Conditions

Keywords

Branch-chained amino acidsEndurance exerciseMetabolomicsSerotonin

Outcome Measures

Primary Outcomes (2)

  • Serotonin

    Serum serotonin concentration

    60 minutes

  • Untargeted metabolomics

    Liquid chromatography mass spectrometry (LCMS) analysis of serum metabolites

    60 minutes

Secondary Outcomes (1)

  • Rating of perceived exertion Borg Scale

    60 minutes

Study Arms (2)

Branched chain amino acid supplementation

EXPERIMENTAL

Consumption of 8 ounces of water with addition of 2.5 g of leucine, 1.25 g of isoleucine, and 1.25 g of valine immediately prior to and again 30 minutes into a 60 minute treadmill run at 65% of VO2max.

Dietary Supplement: Branched Chain Amino Acids

Placebo

PLACEBO COMPARATOR

Consumption of 8 ounces of a flavor matched beverage sweetened with a sucralose-based drink mix immediately prior to and again 30 minutes into a 60 minute treadmill run at 65% of VO2max.

Other: Placebo

Interventions

Branched Chain Amino AcidsDIETARY_SUPPLEMENT

Supplementation with 8 g Nutrex Research Amino Acid Drive BCAA in 8 ounces of water once each immediately pre-exercise and after 30 minutes of exercise

Branched chain amino acid supplementation
PlaceboOTHER

Supplementation with 2.0 milliliters of a sucralose-based drink mix with 8 ounces of water once each immediately pre-exercise and after 30 minutes of exercise

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participate in at least 5 hours of cardiovascular activity per week

You may not qualify if:

  • Any underlying injury
  • The consumption of any selective serotonin re-uptake inhibitor (SSRI) medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montana State University

Bozeman, Montana, 59717, United States

Location

MeSH Terms

Interventions

Amino Acids

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

  • Mary P Miles, PhD

    Montana State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double-blind
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 60 minutes of moderate (65% of VO2max) endurance exercise with either a branched chain amino acid supplement or a placebo consumed immediately prior to and 30 minutes into the exercise bout.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 9, 2021

First Posted

July 20, 2021

Study Start

October 1, 2019

Primary Completion

February 23, 2021

Study Completion

February 23, 2021

Last Updated

May 3, 2023

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations