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OpenTrials
Completed

NCT Number: NCT05484661

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

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.

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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BCAA

Dietary 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.

Primary outcomes

  1. Fatigue

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Acronym: BCAA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 2, 2022
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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