SarcopeniaNCT06376266
Assessment of the Intervention Effectiveness of Branched-chain Amino Acids(BCAA) Combined With Medium-chain Fatty Acid(MCFA) Products in Sarcopenia Among Middle-aged and Elderly Individuals
A study testing nutritional supplements in people with Sarcopenia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Taiwan entered an aging society in 2018 and is expected to transition into a super-aged society by 2025. With the increasing elderly population, age-related diseases pose urgent challenges to modern society. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- nutritional supplements
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2023to 30 Sep 2025
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years
- Diagnosis of sarcopenia or pre-sarcopenia
Who cannot join
- Lack of willingness to participate
- Complete dependence on activities of daily living
- Diagnosis of cancer
- Physician-determined life expectancy of less than two years
- Deemed incapable of undergoing assessment by a physician or clinical assessor
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Geriatrics and Gerontology, National Taiwan University Hospital
Taipei, 100
About this study
Official title: Aged and Elderly Individuals
Taiwan entered an aging society in 2018 and is expected to transition into a super-aged society by 2025. With the increasing elderly population, age-related diseases pose urgent challenges to modern society. According to the Ministry of Health and Welfare's National Health Statistics in 2018, the prevalence of sarcopenia in Taiwan among individuals aged 65 and older is 23.6% for males and 18.6% for females. Sarcopenia, characterized by the loss of skeletal muscle mass due to aging, coupled with decreased muscle strength and/or reduced physical performance, poses a significant risk for disability, decreased quality of life, and increased mortality.
Existing research indicates that appropriate nutrition and exercise can slow the onset of sarcopenia and even increase muscle mass to reverse its effects. This study is an interventional clinical trial recruiting middle-aged and elderly patients with sarcopenia or pre-sarcopenia. The intervention involves a combination of branched-chain amino acids and medium-chain triglyceride products, and the study aims to assess the effectiveness of this intervention for sarcopenia in middle-aged and elderly individuals.
Read the detailed description
Project Rationale:
Taiwan entered an aging society in 2018 and is expected to transition into a super-aged society by 2025. With the increasing elderly population, age-related diseases pose urgent challenges to modern society. According to the Ministry of Health and Welfare's National Health Statistics in 2018, the prevalence of sarcopenia in Taiwan among individuals aged 65 and older is 23.6% for males and 18.6% for females. Sarcopenia, characterized by the loss of skeletal muscle mass due to aging, coupled with decreased muscle strength and/or reduced physical performance, poses a significant risk for disability, decreased quality of life, and increased mortality.
Existing research indicates that appropriate nutrition and exercise can slow the onset of sarcopenia and even increase muscle mass to reverse its effects. This study is an interventional clinical trial recruiting middle-aged and elderly patients with sarcopenia or pre-sarcopenia. The intervention involves a combination of branched-chain amino acids and medium-chain triglyceride products, and the study aims to assess the effectiveness of this intervention for sarcopenia in middle-aged and elderly individuals.
Project Objectives:
Evaluate the effectiveness of branched-chain amino acids combined with medium-chain triglyceride products as an intervention for sarcopenia in middle-aged and elderly individuals.
Methods:
The study cohort will be recruited from National Taiwan University Hospital, targeting individuals aged 50 and above with sarcopenia or pre-sarcopenia. Randomized double-blind allocation will divide participants into intervention and control groups, with each group recruiting 40 subjects (80 participants in total). The intervention group will receive a daily supplement of branched-chain amino acids combined with medium-chain triglycerides, while the control group will be given maltodextrin of the same packaging and quantity as a placebo.
The study will assess various physiological parameters and functional fitness items, conducting the same tests after an 8-week period to evaluate the effectiveness of branched-chain amino acids combined with medium-chain triglyceride products for sarcopenia intervention in middle-aged and elderly individuals.
Expected Outcomes:
Confirmation of the efficacy of nutritional supplements primarily consisting of branched-chain amino acids and medium-chain triglycerides in intervening in muscle loss and promoting daily life functionality in middle-aged and elderly individuals.
Enhanced understanding of the etiology, diagnosis, and assessment methods of sarcopenia among participating staff.
The study anticipates no patent or other commercial interests. If there are any research developments, they will be owned by National Taiwan University Hospital, with potential applications such as publishing academic papers or technology transfer in the future.
- Conditions
- Sarcopenia
- Being tested
- nutritional supplements
- Keywords
- Sarcopenia, branched-chain amino acids(BCAA), medium-chain fatty acid(MCFA)
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional supplementsCombination product
a daily supplement of branched-chain amino acids combined with medium-chain triglycerides
| Study group | Role | What they receive |
|---|---|---|
| receive a daily supplement of branched-chain amino acids combined with medium-chain triglycerides | Active comparator | receive a daily supplement of branched-chain amino acids combined with medium-chain triglycerides Receives: Combination Product: nutritional supplements |
| receive a daily supplement of maltodextrin of the same packaging and quantity | Placebo comparator | receive a daily supplement of maltodextrin of the same packaging and quantity Receives: Combination Product: nutritional supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
the scale of sarcopenia
muscle mass: this study utilizes BIA or DXA to measure the ASMI (kg/ht^2)
Measured: Baseline, 8 weeks
the scale of sarcopenia
muscle strength: Use a handgrip dynamometer to measure the dominant hand grip strength (kgw) of the participants. Take the maximum value of three measurements, with a one-minute interval between each measurement.
Measured: Baseline, 8 weeks
the scale of sarcopenia
physical performance: During testing, participants are required to cross their arms across their chests and record the time (seconds) taken to perform five consecutive sit-to-stand movements and their walking speed (m/s) over a distance of 6 meters.
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start1 Oct 2023
- Primary completion29 Dec 2023
- Study completion30 Sep 2025
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 SarcopeniaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ding-cheng Chan, Dr, Study director, Department of Geriatrics and Gerontology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376266
- Sponsor's protocol ID
- 202305083RSC
- Status last verified
- Jun 2025
- First submitted
- 4 Jan 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan DC, Shiao MS, Huang WJ, Huang CF. Effects of a Multi-Ingredient MCT-Leucine-Creatine-Based Supplement (TLN-01) on Muscle Mass, Strength, and Plasma Amino Acid Profiles in Older Adults with Sarcopenia: A Randomized Controlled Trial. Life (Basel). 2026 Aug 14;16(8):1334. doi: 10.3390/life16081334.
PubMed 42653022
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aged and Elderly Individuals
- ClinicalTrials.gov ID
- NCT06376266
- Acronym / sponsor ID
- 202305083RSC
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, branched-chain amino acids(BCAA), medium-chain fatty acid(MCFA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 19 Apr 2024 (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.
Taiwan entered an aging society in 2018 and is expected to transition into a super-aged society by 2025. With the increasing elderly population, age-related diseases pose urgent challenges to modern society. According to the Ministry of Health and Welfare's National Health Statistics in 2018, the prevalence of sarcopenia in Taiwan among individuals aged 65 and older is 23.6% for males and 18.6% for females. Sarcopenia, characterized by the loss of skeletal muscle mass due to aging, coupled with decreased muscle strength and/or reduced physical performance, poses a significant risk for disability, decreased quality of life, and increased mortality.
Existing research indicates that appropriate nutrition and exercise can slow the onset of sarcopenia and even increase muscle mass to reverse its effects. This study is an interventional clinical trial recruiting middle-aged and elderly patients with sarcopenia or pre-sarcopenia. The intervention involves a combination of branched-chain amino acids and medium-chain triglyceride products, and the study aims to assess the effectiveness of this intervention for sarcopenia in middle-aged and elderly individuals.
Detailed description
Project Rationale:
Taiwan entered an aging society in 2018 and is expected to transition into a super-aged society by 2025. With the increasing elderly population, age-related diseases pose urgent challenges to modern society. According to the Ministry of Health and Welfare's National Health Statistics in 2018, the prevalence of sarcopenia in Taiwan among individuals aged 65 and older is 23.6% for males and 18.6% for females. Sarcopenia, characterized by the loss of skeletal muscle mass due to aging, coupled with decreased muscle strength and/or reduced physical performance, poses a significant risk for disability, decreased quality of life, and increased mortality.
Existing research indicates that appropriate nutrition and exercise can slow the onset of sarcopenia and even increase muscle mass to reverse its effects. This study is an interventional clinical trial recruiting middle-aged and elderly patients with sarcopenia or pre-sarcopenia. The intervention involves a combination of branched-chain amino acids and medium-chain triglyceride products, and the study aims to assess the effectiveness of this intervention for sarcopenia in middle-aged and elderly individuals.
Project Objectives:
Evaluate the effectiveness of branched-chain amino acids combined with medium-chain triglyceride products as an intervention for sarcopenia in middle-aged and elderly individuals.
Methods:
The study cohort will be recruited from National Taiwan University Hospital, targeting individuals aged 50 and above with sarcopenia or pre-sarcopenia. Randomized double-blind allocation will divide participants into intervention and control groups, with each group recruiting 40 subjects (80 participants in total). The intervention group will receive a daily supplement of branched-chain amino acids combined with medium-chain triglycerides, while the control group will be given maltodextrin of the same packaging and quantity as a placebo.
The study will assess various physiological parameters and functional fitness items, conducting the same tests after an 8-week period to evaluate the effectiveness of branched-chain amino acids combined with medium-chain triglyceride products for sarcopenia intervention in middle-aged and elderly individuals.
Expected Outcomes:
Confirmation of the efficacy of nutritional supplements primarily consisting of branched-chain amino acids and medium-chain triglycerides in intervening in muscle loss and promoting daily life functionality in middle-aged and elderly individuals.
Enhanced understanding of the etiology, diagnosis, and assessment methods of sarcopenia among participating staff.
The study anticipates no patent or other commercial interests. If there are any research developments, they will be owned by National Taiwan University Hospital, with potential applications such as publishing academic papers or technology transfer in the future.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| receive a daily supplement of branched-chain amino acids combined with medium-chain triglycerides | Active comparator | Combination Product: nutritional supplementsreceive a daily supplement of branched-chain amino acids combined with medium-chain triglycerides |
| receive a daily supplement of maltodextrin of the same packaging and quantity | Placebo comparator | Combination Product: nutritional supplementsreceive a daily supplement of maltodextrin of the same packaging and quantity |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 50 years
- Diagnosis of sarcopenia or pre-sarcopenia
Key exclusion criteria (5 listed)
- Lack of willingness to participate
- Complete dependence on activities of daily living
- Diagnosis of cancer
- Physician-determined life expectancy of less than two years
- Deemed incapable of undergoing assessment by a physician or clinical assessor
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 |
|---|---|---|
| nutritional supplementsa daily supplement of branched-chain amino acids combined with medium-chain triglycerides | Combination product | receive a daily supplement of branched-chain amino acids combined with medium-chain triglycerides, receive a daily supplement of maltodextrin of the same packaging and quantity |
Primary outcome
the scale of sarcopenia
Time frame: Baseline, 8 weeks
muscle mass: this study utilizes BIA or DXA to measure the ASMI (kg/ht^2)
the scale of sarcopenia
Time frame: Baseline, 8 weeks
muscle strength: Use a handgrip dynamometer to measure the dominant hand grip strength (kgw) of the participants. Take the maximum value of three measurements, with a one-minute interval between each measurement.
the scale of sarcopenia
Time frame: Baseline, 8 weeks
physical performance: During testing, participants are required to cross their arms across their chests and record the time (seconds) taken to perform five consecutive sit-to-stand movements and their walking speed (m/s) over a distance of 6 meters.
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 29 Apr 2026.
- Derived from this study: PubMed 42653022Chan DC, Shiao MS, Huang WJ, Huang CF. Effects of a Multi-Ingredient MCT-Leucine-Creatine-Based Supplement (TLN-01) on Muscle Mass, Strength, and Plasma Amino Acid Profiles in Older Adults with Sarcopenia: A Randomized Controlled Trial. Life (Basel). 2026 Aug 14;16(8):1334. doi: 10.3390/life16081334.
- 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.
Ding-cheng Chan, Dr study director
Department of Geriatrics and Gerontology, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutritional supplements in people with Sarcopenia, run by National Taiwan University Hospital at 1 site 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 2 inclusion and 5 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 29 Apr 2026. 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 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?
the scale of sarcopenia (time frame: Baseline, 8 weeks). The study lists 3 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 NCT06376266, 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 29 Apr 2026.