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

Primary Purpose

Fatigue, Aging

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BCAA
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue focused on measuring Branched Chain Amino Acids, Exercise

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas Health Science Center at San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Exercise + BCAA

Exercise + Placebo

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Blood and Skeletal Muscle kynurenine
Participants will undergo blood draws and muscle biopsies for assessment of circulating and skeletal muscle knurenine (nmol/L)

Full Information

First Posted
July 28, 2022
Last Updated
July 14, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
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1. Study Identification

Unique Protocol Identification Number
NCT05484661
Brief Title
Mechanisms to Reduce Mental and Physical Fatigue Following Exercise Training in Older Adults
Acronym
BCAA
Official Title
Mechanisms to Reduce Mental and Physical Fatigue Following Exercise Training in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 22, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at San Antonio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Aging
Keywords
Branched Chain Amino Acids, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise + BCAA
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercise + Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
BCAA
Intervention Description
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 Outcome Measure Information:
Title
Fatigue
Description
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)
Time Frame
change from baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Blood and Skeletal Muscle kynurenine
Description
Participants will undergo blood draws and muscle biopsies for assessment of circulating and skeletal muscle knurenine (nmol/L)
Time Frame
change from baseline to 8 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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