Purpose

Fatigue is a strong predictor of negative health outcomes in older adults. The research in this study will compare the effects of 8-weeks of branched chain amino acids (BCAA: dietary supplements commonly taken to improve muscle growth and exercise performance) added to exercise compared to exercise with a placebo (inactive, harmless substance). BCAAs could have an impact on improving fatigue common in older adults, especially when exercising. We will examine the effects of an 8-week exercise program when combined with either BCAAs or a placebo 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 in the skeletal muscle and blood.

Category

IRB Number
20220493HU
NCT Number
NCT05484661
Open to Enrollment
Yes
Sponsor
The University of Texas Health Science Center at San Antonio -



Study Contact

Principal Investigator
Monica Serra

Tiffany Cortes
(210) 450-8998
cortest@uthscsa.edu

Sandra Idar
(210) 450-0568
idars@uthscsa.edu



Eligibility

Eligible Ages
60-80
Eligible Genders
All
Accepts Healthy Volunteers
No

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 (no more than 2x/week)

Exclusion Criteria

    taking an anticoagulant medication (i.e., heparin, apixaban, rivaroxaban);

    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), gastrointestinal, and uncontrolled psychiatric disease; cognitive impairment; consuming nutritional supplements (excluding common multi-mineral/vitamin); uncontrolled depression


Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Condition
  • Fatigue
  • Aging
  • Arm Groups

    ArmDescriptionIntervention
    Placebo Comparator

    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.
  • 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.

  • Experimental

    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.
  • 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.