Aging, Fatigue
Conditions
Keywords
Branched Chain Amino Acids, Exercise
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.
Interventions
DIETARY_SUPPLEMENTBCAA
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.
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
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 (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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | change from baseline to 8 weeks | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Exercise + BCAA | Exercise + Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 20 Participants | 10 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 70.0 years STANDARD_DEVIATION 3.3 | 71.4 years STANDARD_DEVIATION 3.6 | 70.0 years STANDARD_DEVIATION 3.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 10 Participants | 9 Participants |
| Region of Enrollment United States | 20 participants | 10 participants | 10 participants |
| Sex: Female, Male Female | 12 Participants | 3 Participants | 9 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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)
Time frame: change from baseline to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise + BCAA | Fatigue | -5.6 change in fatigue severity score | Standard Deviation 4 |
| Exercise + Placebo | Fatigue | -4.1 change in fatigue severity score | Standard Deviation 3.1 |