StrokeNCT03244527
Use of BCAA-rich Protein Supplements for Chronic Stroke Patients
A study testing BCAA supplement and Aerobic exercise in people with Stroke, run by Taipei Medical University WanFang Hospital at 2 sites in Taiwan.
Trial summary
In the past few years, Branched Chain Amino Acid (BCAA) supplements have gradually used on different groups. From training athletes, maintaining functions of healthy elders to preventing disabilities of people that can't do intense exercises. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- BCAA supplement and Aerobic exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesTaiwan
- Study dates
- 29 Aug 2017to 5 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic stroke>6months
- Age : 20-75 y
- Able to walk independently over 30 mins (with or without orthosis)
- Able to use stationary bike
Who cannot join
- Physiological condition not stable, cognitive dysfunction, not able to coordinate with examine or treatments.
- Not able to exercise due to severe cardiopulmonary dysfunction
- Malnutrition (MNA<11)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Use of BCAA-rich Protein Supplements for Chronic Stroke Patients to Improve the Functional Performance
In the past few years, Branched Chain Amino Acid (BCAA) supplements have gradually used on different groups. From training athletes, maintaining functions of healthy elders to preventing disabilities of people that can't do intense exercises. BCAAs are now considered to be able to prevent muscle atrophy and strength loss, also possible to increase strength and muscle mass if combined with resistance exercises. Stroke patients have difficulties with moving, which led to multiple disabilities, are more likely to have sarcopenia and strength loss. Furthermore, reducing the will of moving or walking. Recently, studies showed that combined BCAAs with resistance exercises can effectively increase muscle mass, thus commonly used on training athletes.
Although aerobic exercises are proven to be more likely to improve walking ability of chronic stroke patients than traditional rehabilitation, BCAAs' effects are yet to be proven. Therefore, the aim of this study is to explore if BCAAs combined with moderate intensity exercises can prevent muscle atrophy, loss of strength and cardiopulmonary function.
This is a randomized control trial. Participants are randomly assigned to either experiment or control groups. Both group received aerobic exercise (30 min in a session, 3 days a week, and for 8 weeks). Experiment group received BCAA supplement immediately after the exercise while the control group receive sham product (vitamins). The outcome measurements (including muscle mass, functional measures, and quality of life) are performed before (0-wk) and after (8-wk) the interventions, also after interventions in 3 months and 6 months for follow up.
Read the detailed description
Setting : inpatient rehabilitation department of Wan-Fang Hospital and Shuang-Ho Hospital Study population : Patients received inpatient treatment or rehabilitation for stroke in Wan-Fang Hospital (WFH) and Shuang-Ho Hospital (SHH).
Study design: controlled trial with randomization Blinding : The patients were blinded by the real or sham bcaa supplements. The assessors who performed the outcome measurements were blinded to the assignment of treatment.
Measurements : DXA(Dual-energy X-ray absorptiometry),CPET(Cardiopulmonary Exercise Testing),6 minute walk test,Timed up and go,Berg balance test,Stroke Specific Quality of Life Scale (SS-QOL).
These measurements (including the clinical and corticomotor excitability assessments) are performed by one researcher who are responsible for the measurements.
Compliance and side effect. The compliance of supplements were investigated. The attendance of treatments (including bcaa supplements and physical therapy sessions) and possible side effect/discomfort were recorded during the interventions by a researcher. He also tries to understand the reason of drop-out from the study.
- Conditions
- Stroke
- Being tested
- BCAA supplement, Aerobic exercise
- Keywords
- BCAA, stroke, mobility
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCAA supplementDietary supplement
Before each exercise session (described later), the research assistant will give subjects 40g of BCAA or placebo supplement according to the treatment assignment and ask them to drink it down right away.
Aerobic exerciseOther
The exercise intervention includes 24 aerobic stationary cycling sessions (30 min/session, 3 session/week, and 8 weeks). The exercise sessions proceed under the supervision and guidance of a therapist.
| Study group | Role | What they receive |
|---|---|---|
| BCAA group | Experimental | Participants in the BCAA group take 40g of BCAA supplement before each aerobic exercise session. The interventions include 24 aerobic training sessions. Accordingly, the participants intake 960g of BCAA during a 8-week intervention period. Receives: Dietary Supplement: BCAA supplement; Other: Aerobic exercise |
| Control group | Placebo comparator | Participants in the control group take 40g of placebo before each aerobic training session. The placebo has the same caloric as the BCAA supplement but with different constitution (eg, different percentage of protein, fat and carbohydrate) Receives: Dietary Supplement: BCAA supplement; Other: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
DXA
Measured: 8 weeks after intervention
Body fat scale
Measured: 8 weeks after intervention
Secondary outcomes (5)
Timed up and go (TUG)
Measured: 8 weeks after intervention
Burg Balance Test
Measured: 8 weeks after intervention
CPET
Measured: 8 weeks after intervention
Stroke Specific Quality of Life Scale(SS-QOL)
Measured: 8 weeks after intervention
6 minutes walk test
Measured: 8 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start29 Aug 2017
- Primary completion2 Aug 2018
- Study completion5 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yen-Nung Lin, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244527
- Sponsor's protocol ID
- N201703029
- Status last verified
- Mar 2020
- First submitted
- 21 Jul 2017
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cheng YH, Wei L, Chan WP, Hsu CY, Huang SW, Wang H, Lin YN. Effects of protein supplementation on aerobic training-induced gains in cardiopulmonary fitness, muscle mass, and functional performance in chronic stroke: A randomized controlled pilot study. Clin Nutr. 2020 Sep;39(9):2743-2750. doi: 10.1016/j.clnu.2019.12.013. Epub 2019 Dec 17.
PubMed 31879077
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of BCAA-rich Protein Supplements for Chronic Stroke Patients to Improve the Functional Performance
- ClinicalTrials.gov ID
- NCT03244527
- Acronym / sponsor ID
- N201703029
- Conditions
- Stroke
- Keywords
- BCAA, stroke, mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 2 Aug 2018 (actual)
- Study completion
- 5 Aug 2018 (actual)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the past few years, Branched Chain Amino Acid (BCAA) supplements have gradually used on different groups. From training athletes, maintaining functions of healthy elders to preventing disabilities of people that can't do intense exercises. BCAAs are now considered to be able to prevent muscle atrophy and strength loss, also possible to increase strength and muscle mass if combined with resistance exercises. Stroke patients have difficulties with moving, which led to multiple disabilities, are more likely to have sarcopenia and strength loss. Furthermore, reducing the will of moving or walking. Recently, studies showed that combined BCAAs with resistance exercises can effectively increase muscle mass, thus commonly used on training athletes.
Although aerobic exercises are proven to be more likely to improve walking ability of chronic stroke patients than traditional rehabilitation, BCAAs' effects are yet to be proven. Therefore, the aim of this study is to explore if BCAAs combined with moderate intensity exercises can prevent muscle atrophy, loss of strength and cardiopulmonary function.
This is a randomized control trial. Participants are randomly assigned to either experiment or control groups. Both group received aerobic exercise (30 min in a session, 3 days a week, and for 8 weeks). Experiment group received BCAA supplement immediately after the exercise while the control group receive sham product (vitamins). The outcome measurements (including muscle mass, functional measures, and quality of life) are performed before (0-wk) and after (8-wk) the interventions, also after interventions in 3 months and 6 months for follow up.
Detailed description
Setting : inpatient rehabilitation department of Wan-Fang Hospital and Shuang-Ho Hospital Study population : Patients received inpatient treatment or rehabilitation for stroke in Wan-Fang Hospital (WFH) and Shuang-Ho Hospital (SHH).
Study design: controlled trial with randomization Blinding : The patients were blinded by the real or sham bcaa supplements. The assessors who performed the outcome measurements were blinded to the assignment of treatment.
Measurements : DXA(Dual-energy X-ray absorptiometry),CPET(Cardiopulmonary Exercise Testing),6 minute walk test,Timed up and go,Berg balance test,Stroke Specific Quality of Life Scale (SS-QOL).
These measurements (including the clinical and corticomotor excitability assessments) are performed by one researcher who are responsible for the measurements.
Compliance and side effect. The compliance of supplements were investigated. The attendance of treatments (including bcaa supplements and physical therapy sessions) and possible side effect/discomfort were recorded during the interventions by a researcher. He also tries to understand the reason of drop-out from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCAA group | Experimental | Dietary Supplement: BCAA supplement, Other: Aerobic exerciseParticipants in the BCAA group take 40g of BCAA supplement before each aerobic exercise session. The interventions include 24 aerobic training sessions. Accordingly, the participants intake 960g of BCAA during a 8-week intervention period. |
| Control group | Placebo comparator | Dietary Supplement: BCAA supplement, Other: Aerobic exerciseParticipants in the control group take 40g of placebo before each aerobic training session. The placebo has the same caloric as the BCAA supplement but with different constitution (eg, different percentage of protein, fat and carbohydrate) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic stroke>6months
- Age : 20-75 y
- Able to walk independently over 30 mins (with or without orthosis)
- Able to use stationary bike
Key exclusion criteria (3 listed)
- Physiological condition not stable, cognitive dysfunction, not able to coordinate with examine or treatments.
- Not able to exercise due to severe cardiopulmonary dysfunction
- Malnutrition (MNA<11)
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 |
|---|---|---|
| BCAA supplementBefore each exercise session (described later), the research assistant will give subjects 40g of BCAA or placebo supplement according to the treatment assignment and ask them to drink it down right away. | Dietary supplement | BCAA group, Control group |
| Aerobic exerciseThe exercise intervention includes 24 aerobic stationary cycling sessions (30 min/session, 3 session/week, and 8 weeks). The exercise sessions proceed under the supervision and guidance of a therapist. | Other | BCAA group, Control group |
Primary outcome
DXA
Time frame: 8 weeks after intervention
Body fat scale
Time frame: 8 weeks after intervention
5 secondary outcomes
Timed up and go (TUG)
Time frame: 8 weeks after intervention
Burg Balance Test
Time frame: 8 weeks after intervention
CPET
Time frame: 8 weeks after intervention
Stroke Specific Quality of Life Scale(SS-QOL)
Time frame: 8 weeks after intervention
6 minutes walk test
Time frame: 8 weeks after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Derived from this study: PubMed 31879077Cheng YH, Wei L, Chan WP, Hsu CY, Huang SW, Wang H, Lin YN. Effects of protein supplementation on aerobic training-induced gains in cardiopulmonary fitness, muscle mass, and functional performance in chronic stroke: A randomized controlled pilot study. Clin Nutr. 2020 Sep;39(9):2743-2750. doi: 10.1016/j.clnu.2019.12.013. Epub 2019 Dec 17.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCAA supplement and Aerobic exercise in people with Stroke, run by Taipei Medical University WanFang Hospital at 2 sites in Taiwan.
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 3 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 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
DXA (time frame: 8 weeks after intervention). The study lists 2 primary outcomes in all. 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 NCT03244527, 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 17 Mar 2020.