Mechanisms to Reduce Mental and Physical Fatigue Following Exercise Training in Older Adults (BCAA)

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.

Study Overview

• Status: Completed
• Conditions: Fatigue; Aging
• Intervention / Treatment: Dietary supplement: BCAA

Detailed Description

Thirty participants will be asked to participate in this research study. They will be randomized (like a flip of a coin) to exercise + a placebo or exercise + BCAAs for 8 weeks. We would like to examine the effects of the 8-week exercise + dietary supplement program on body composition (fat and muscle), physical activity habits, fatigue, and physical performance (such as walking and strength). We would also like to assess whether these outcomes are controlled by changes in markers (kynurenine metabolites) in the skeletal muscle and blood.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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
• Any disease or condition considered to be exclusionary based on the clinical opinion and discretion of the principal investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise + BCAA; 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; 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.
Placebo Comparator: Exercise + Placebo; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood and Skeletal Muscle kynurenine	Participants will undergo blood draws and muscle biopsies for assessment of circulating and skeletal muscle knurenine (nmol/L)	change from baseline to 8 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2022
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: July 29, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Branched Chain Amino Acids
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: 20220493H

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