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

Aging Clinical Trial

— BCAA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05484661
• Other study ID #: 20220493H
• Status: Completed
• Phase: N/A
• Start date: December 22, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: April 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Fatigue

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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