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

NCT ID: NCT05484661

Last Updated: 2024-11-21

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-22

Study Completion Date

2023-11-30

Brief Summary

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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

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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.

Conditions

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Fatigue Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

BCAA

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

BCAA

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Monica Serra

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37910166 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20220493H

Identifier Type: -

Identifier Source: org_study_id

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