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

Study Overview
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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.

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

Conditions
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Fatigue, Aging

Intervention / Treatment
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* Dietary Supplement: BCAA


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise + BCAA<br>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. | Dietary Supplement: BCAA<br>* 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.<br>|
| Placebo Comparator: Exercise + Placebo<br>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. | Dietary Supplement: BCAA<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Branched Chain Amino Acids, Exercise