NCT05484661

Brief Summary

Fatigue is a strong predictor of negative health outcomes in older adults. The research in this study will compared the effects of 8-weeks of branched chain amino acids (BCAAs: dietary supplements commonly taken to improve muscle growth and exercise performance) added to exercise on fatigue compared to exercise with a placebo (an inactive, harmless substance). BCAAs could have an impact on improving fatigue common in older adults, especially when exercising.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

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

July 28, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 2, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

December 22, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
12 months until next milestone

Results Posted

Study results publicly available

November 21, 2024

Completed
Last Updated

November 21, 2024

Status Verified

October 1, 2024

Enrollment Period

11 months

First QC Date

July 28, 2022

Results QC Date

May 17, 2024

Last Update Submit

October 10, 2024

Conditions

FatigueAging

Keywords

Branched Chain Amino AcidsExercise

Outcome Measures

Primary Outcomes (1)

  • Fatigue

    Participants will complete the Fatigue Assessment Scale questionnaire (Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest)

    change from baseline to 8 weeks

Study Arms (2)

Exercise + BCAA

EXPERIMENTAL

Exercise will include a 3x/wk for eight weeks exercise protocol is designed to provide a high-volume, moderate-intensity whole body training stimulus. BCAA will include \~7-10 g of BCAAs (100 mg/kg) daily for eight weeks.

Dietary Supplement: BCAA

Exercise + Placebo

PLACEBO COMPARATOR

Exercise will include a 3x/wk for eight weeks exercise protocol is designed to provide a high-volume, moderate-intensity whole body training stimulus. Placebo will include \~7-10 g of maltodextrin (100 mg/kg) daily for eight weeks.

Dietary Supplement: BCAA

Interventions

BCAADIETARY_SUPPLEMENT

Participants will participate in high-volume, moderate-intensity exercise 3x/week and consume either a placebo or BCAA (\~7-10 g of BCAAs (100 mg/kg) daily for eight weeks.

Exercise + BCAAExercise + Placebo

Eligibility Criteria

Age60 Years - 80 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fatigue (participants reporting ≥3 on a 1-10 scale)
  • Lack of menses for at least one year for women
  • BMI 20-50 kg/m2
  • Untrained with regard to structured exercise training (is not currently training more than 2x/week)

You may not qualify if:

  • Taking an anticoagulant medication that is unable to be discontinued before biopsies
  • Allergic to lidocaine
  • Neurologic, musculoskeletal, or other condition that limits subject's ability to complete study physical assessments or training
  • Hepatic (LFTs \>2.5xWNL), renal (eGFR\<45), , and uncontrolled psychiatric disease
  • Cognitive impairment
  • Uncontrolled depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

  • Robbins RN, Cortes T, O'Connor JC, Jiwani R, Serra MC. The Influence of Branched-Chain Amino Acid Supplementation on Fatigue and Tryptophan Metabolism After Acute and Chronic Exercise in Older Adults: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Nov 1;12:e52199. doi: 10.2196/52199.

    PMID: 37910166DERIVED

MeSH Terms

Conditions

FatigueMotor Activity

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavior

Results Point of Contact

Title
Monica Serra
Organization
UT Health San Antonio
serram@Uthscsa.edu
210-949-9759

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 28, 2022

First Posted

August 2, 2022

Study Start

December 22, 2022

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

November 21, 2024

Results First Posted

November 21, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)