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

Not Applicable

Completed

• Conditions: Aging; Fatigue
• Interventions: Dietary Supplement: BCAA

• Registration Number: NCT05484661
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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.

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 Timeline

• Study First Submitted: 2022-07-28
• Study First Submitted QC: 2022-07-29
• Study First Posted: 2022-08-02
• Study Start: 2022-12-22
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Results First Submitted: 2024-05-17
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-10
• Last Update Submitted: 2024-10-10
• Results First Posted: 2024-11-21
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise + BCAA	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.
Exercise + Placebo	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. Placebo will include \~7-10 g of maltodextrin (100 mg/kg) daily for eight weeks.

Primary Outcome Measures

Name	Time	Method
Fatigue	change from baseline to 8 weeks	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)

Trial Locations

Locations (1)

University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States