FatigueBCAANCT05484661
Mechanisms to Reduce Mental and Physical Fatigue Following Exercise Training in Older Adults
A study testing BCAA in people with Fatigue and Aging, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- What is being tested?
- BCAA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
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.
Read the 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.
- Being tested
- BCAA
- Keywords
- Branched Chain Amino Acids, Exercise
- Medical subject headings
- Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCAADietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise + BCAA | Experimental | 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. Receives: Dietary Supplement: BCAA |
| Exercise + Placebo | Placebo comparator | 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. Receives: Dietary Supplement: BCAA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: change from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start22 Dec 2022
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Serra, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484661
- Sponsor's protocol ID
- 20220493H
- Acronym
- BCAA
- Status last verified
- Oct 2024
- First submitted
- 28 Jul 2022
- Last updated
- 21 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37910166
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms to Reduce Mental and Physical Fatigue Following Exercise Training in Older Adults
- ClinicalTrials.gov ID
- NCT05484661
- Acronym / sponsor ID
- BCAA / 20220493H
- Keywords
- Branched Chain Amino Acids, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 2 Aug 2022 (actual)
- Results
- Posted 21 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise + BCAA | Experimental | Dietary Supplement: BCAAExercise 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 + Placebo | Placebo comparator | Dietary Supplement: BCAAExercise 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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCAAParticipants 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. | Dietary supplement | Exercise + BCAA, Exercise + Placebo |
Primary outcome
Fatigue
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37910166Robbins 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCAA in people with Fatigue and Aging, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: change from baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05484661, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.