SarcopeniaNCT06991855
Effects of Nutritional Supplementation of Leucine and Polyunsaturated Fatty Acids on Muscle Health in the Elderly
A study testing Animal-Based Oil Group and Plant-Based Oil Group in people with Sarcopenia and Sarcopenia in Elderly, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Population aging has become a significant global concern, and Taiwan is set to officially enter the "super-aged society" in 2025. As individuals age, various physiological functions gradually decline, including a reduction in muscle mass, which is a key aspect of the aging process. Read more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Sarcopenia, Sarcopenia in Elderly
- What is being tested?
- Animal-Based Oil Group and Plant-Based Oil Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2025to 17 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years
- ASMI < 7 kg/m2 in men
- ASMI < 5.7 kg/m2 in women
- Grip strength < 28 kg in men
- Grip strength < 18 kg in women
- Walk speed < 1 m/s
Who cannot join
- People who are allergic to supplements
- cancer
- heart failure
- kidney disease
- autoimmune disease
- neurodegenerative disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Linkou District, 333
Yi-Tsang Chen, +886-2-2712-2211 ext. 7358, ytchen@fpg.com.tw
About this study
Official title: Explore the Effects of Nutritional Supplementation of Leucine and Polyunsaturated Fatty Acids on Muscle Health in the Elderly
Population aging has become a significant global concern, and Taiwan is set to officially enter the "super-aged society" in 2025. As individuals age, various physiological functions gradually decline, including a reduction in muscle mass, which is a key aspect of the aging process.
This interventional study aims to investigate the effects of leucine-rich protein combined with polyunsaturated fatty acid supplementation on middle-aged and elderly individuals (aged 50 and above) who are at high risk for sarcopenia.
- Conditions
- Sarcopenia, Sarcopenia in Elderly
- Being tested
- Animal-Based Oil Group, Plant-Based Oil Group
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal-Based Oil GroupDietary supplement
Participants in animal-based oil group will follow a diet in which the primary fat source is animal-based oil. The diet will supplement for 12 weeks.
Plant-Based Oil GroupDietary supplement
Participants in plant-based oil group will follow a diet in which the primary fat source is plant-based oil. The diet will supplement for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Animal-Based Oil Group | Experimental | Participants in this group will supplement with animal-based poly-unsaturated oil. The supplementation will be maintained for 12 weeks. Receives: Dietary Supplement: Animal-Based Oil Group |
| Plant-Based Oil Group | Experimental | Participants in this group will supplement with plant-based poly-unsaturated oil. The supplementation will be maintained for 12 weeks. Receives: Dietary Supplement: Plant-Based Oil Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle mass
Utilize Bioelectrical Impedance Analysis (BIA) to measure the Appendicular Skeletal Muscle Mass Index Level (ASMI) (kg/m^2)
Measured: baseline, 12 weeks
muscle function
utilize handgrip dynamometer to measure the hand grip strength (kg).
Measured: baseline, 12 weeks
physical function
To assess the participant's walking speed over a 4-meter distance.
Measured: baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start1 Jul 2025 (estimated)
- Primary completion10 Apr 2026 (estimated)
- Study completion17 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung University
- Responsible party
- Principal investigator, JI-TSENG FANG, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991855
- Sponsor's protocol ID
- 202500394A3
- Status last verified
- Jun 2025
- First submitted
- 27 May 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore the Effects of Nutritional Supplementation of Leucine and Polyunsaturated Fatty Acids on Muscle Health in the Elderly
- ClinicalTrials.gov ID
- NCT06991855
- Acronym / sponsor ID
- 202500394A3
- Conditions
- Sarcopenia, Sarcopenia in Elderly
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Chang Gung University
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 10 Apr 2026 (estimated)
- Study completion
- 17 Apr 2026 (estimated)
- First posted
- 28 May 2025 (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.
Population aging has become a significant global concern, and Taiwan is set to officially enter the "super-aged society" in 2025. As individuals age, various physiological functions gradually decline, including a reduction in muscle mass, which is a key aspect of the aging process.
This interventional study aims to investigate the effects of leucine-rich protein combined with polyunsaturated fatty acid supplementation on middle-aged and elderly individuals (aged 50 and above) who are at high risk for sarcopenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Animal-Based Oil Group | Experimental | Dietary Supplement: Animal-Based Oil GroupParticipants in this group will supplement with animal-based poly-unsaturated oil. The supplementation will be maintained for 12 weeks. |
| Plant-Based Oil Group | Experimental | Dietary Supplement: Plant-Based Oil GroupParticipants in this group will supplement with plant-based poly-unsaturated oil. The supplementation will be maintained for 12 weeks. |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 50 years
- ASMI < 7 kg/m2 in men
- ASMI < 5.7 kg/m2 in women
- Grip strength < 28 kg in men
- Grip strength < 18 kg in women
Key exclusion criteria (6 listed)
- People who are allergic to supplements
- cancer
- heart failure
- kidney disease
- autoimmune disease
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 |
|---|---|---|
| Animal-Based Oil GroupParticipants in animal-based oil group will follow a diet in which the primary fat source is animal-based oil. The diet will supplement for 12 weeks. | Dietary supplement | Animal-Based Oil Group |
| Plant-Based Oil GroupParticipants in plant-based oil group will follow a diet in which the primary fat source is plant-based oil. The diet will supplement for 12 weeks. | Dietary supplement | Plant-Based Oil Group |
Primary outcome
muscle mass
Time frame: baseline, 12 weeks
Utilize Bioelectrical Impedance Analysis (BIA) to measure the Appendicular Skeletal Muscle Mass Index Level (ASMI) (kg/m^2)
muscle function
Time frame: baseline, 12 weeks
utilize handgrip dynamometer to measure the hand grip strength (kg).
physical function
Time frame: baseline, 12 weeks
To assess the participant's walking speed over a 4-meter distance.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal-Based Oil Group and Plant-Based Oil Group in people with Sarcopenia and Sarcopenia in Elderly, run by Chang Gung Memorial 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 22 Jun 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsiang-Yu Tang, Ph.D. (+886-3-2118800 ext. 3650, tangshyu@cgu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle mass (time frame: baseline, 12 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?
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 22 Jun 2025.