Low Muscle MassNCT07309120
Nutrition Ameliorates the Muscle Loss of Pre-sarcopenia in Elderly
A study testing Participants consume two sachets daily over a 12-week intervention period. in people with Low Muscle Mass and Low Muscle Strength, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This study evaluates the effects of a 12-week leucine-enriched protein supplementation in adults aged 60 years and more. Participants will undergo assessments of muscle mass and function, as well as metabolic profiles in blood, urine, and feces before and after the intervention. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Muscle Mass, Low Muscle Strength, Low Physical Function
- What is being tested?
- Participants consume two sachets daily over a 12-week intervention period.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Dec 2021to 20 Jun 2023
- 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 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing to provide written informed consent.
- Participants who attend health check-ups at Songshan District, Taipei City, or at the Wellness Cultural Village, or who have participated in the pilot study.
- Adults aged 60 years or older, male or female.
- Able to ambulate independently.
- Meets at least one of the following sarcopenia criteria:
- Grip strength: Men < 28 kg; Women < 18 kg Gait speed: < 1.0 m/s Muscle mass (appendicular skeletal muscle mass / height²): Men < 7.0 kg/m²; Women < 5.7 kg/m²
Who cannot join
- Impaired renal function.
- Allergy or intolerance to protein supplements.
- Currently undergoing cancer treatment.
- Autoimmune diseases.
- Assessed by a physician as unsuitable to participate.
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the effects of a 12-week leucine-enriched protein supplementation in adults aged 60 years and more. Participants will undergo assessments of muscle mass and function, as well as metabolic profiles in blood, urine, and feces before and after the intervention.
- Conditions
- Low Muscle Mass, Low Muscle Strength, Low Physical Function
- Being tested
- Participants consume two sachets daily over a 12-week intervention period.
- Keywords
- metabolomics, supplemenation, pre-sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants consume two sachets daily over a 12-week intervention period.Dietary supplement
Each 8 g serving provided 35 kcal, comprising 4.1 g of protein, 1 g of fat, and 2.4 g of carbohydrates.
| Study group | Role | What they receive |
|---|---|---|
| Protein Supplementation Group | Experimental | Not described Receives: Dietary Supplement: Participants consume two sachets daily over a 12-week intervention period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appendicular Skeletal Muscle Index (ASMI)
Muscle mass was assessed using bioelectrical impedance analysis (Tanita MC-780MA). The appendicular skeletal muscle index (ASMI, kg/m2) was calculated as appendicular skeletal muscle mass (ASM, kg) divided by height squared (m²).
Measured: Baseline and 12 weeks after intervention
Handgrip Strength (HGS)
Functional performance was evaluated by handgrip strength (HGS, kg), measured with a digital hand dynamometer.
Measured: Baseline and 12 weeks after intervention
Gait speed (m/s)
Gait speed was assessed as the time required to walk a 4 meters, expressed in meters per second (m/s).
Measured: Baseline and 12 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 posted30 Dec 2025
- Study start24 Dec 2021
- Primary completion31 May 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Muscle MassStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309120
- Sponsor's protocol ID
- 202100551A3
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to ethical and privacy considerations, individual participant data will not be publicly available. De-identified data may be shared upon reasonable request and with approval from the institutional review board.
Publications
Prado CM, Landi F, Chew STH, Atherton PJ, Molinger J, Ruck T, Gonzalez MC. Advances in muscle health and nutrition: A toolkit for healthcare professionals. Clin Nutr. 2022 Oct;41(10):2244-2263. doi: 10.1016/j.clnu.2022.07.041. Epub 2022 Aug 7.
PubMed 36081299Lee SY, Lee HJ, Lim JY. Effects of leucine-rich protein supplements in older adults with sarcopenia: A systematic review and meta-analysis of randomized controlled trials. Arch Gerontol Geriatr. 2022 Sep-Oct;102:104758. doi: 10.1016/j.archger.2022.104758. Epub 2022 Jun 24.
PubMed 35777246
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Ameliorates the Muscle Loss of Pre-sarcopenia in Elderly
- ClinicalTrials.gov ID
- NCT07309120
- Acronym / sponsor ID
- 202100551A3
- Conditions
- Low Muscle Mass, Low Muscle Strength, Low Physical Function
- Keywords
- metabolomics, supplemenation, pre-sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 24 Dec 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 30 Dec 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.
This study evaluates the effects of a 12-week leucine-enriched protein supplementation in adults aged 60 years and more. Participants will undergo assessments of muscle mass and function, as well as metabolic profiles in blood, urine, and feces before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Protein Supplementation Group | Experimental | Dietary Supplement: Participants consume two sachets daily over a 12-week intervention period. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Willing to provide written informed consent.
- Participants who attend health check-ups at Songshan District, Taipei City, or at the Wellness Cultural Village, or who have participated in the pilot study.
- Adults aged 60 years or older, male or female.
- Able to ambulate independently.
- Meets at least one of the following sarcopenia criteria:
Key exclusion criteria (5 listed)
- Impaired renal function.
- Allergy or intolerance to protein supplements.
- Currently undergoing cancer treatment.
- Autoimmune diseases.
- Assessed by a physician as unsuitable to participate.
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 |
|---|---|---|
| Participants consume two sachets daily over a 12-week intervention period.Each 8 g serving provided 35 kcal, comprising 4.1 g of protein, 1 g of fat, and 2.4 g of carbohydrates. | Dietary supplement | Protein Supplementation Group |
Primary outcome
Appendicular Skeletal Muscle Index (ASMI)
Time frame: Baseline and 12 weeks after intervention
Muscle mass was assessed using bioelectrical impedance analysis (Tanita MC-780MA). The appendicular skeletal muscle index (ASMI, kg/m2) was calculated as appendicular skeletal muscle mass (ASM, kg) divided by height squared (m²).
Handgrip Strength (HGS)
Time frame: Baseline and 12 weeks after intervention
Functional performance was evaluated by handgrip strength (HGS, kg), measured with a digital hand dynamometer.
Gait speed (m/s)
Time frame: Baseline and 12 weeks after intervention
Gait speed was assessed as the time required to walk a 4 meters, expressed in meters per second (m/s).
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 8 Jan 2026.
- Background: PubMed 36081299Prado CM, Landi F, Chew STH, Atherton PJ, Molinger J, Ruck T, Gonzalez MC. Advances in muscle health and nutrition: A toolkit for healthcare professionals. Clin Nutr. 2022 Oct;41(10):2244-2263. doi: 10.1016/j.clnu.2022.07.041. Epub 2022 Aug 7.
- Background: PubMed 35777246Lee SY, Lee HJ, Lim JY. Effects of leucine-rich protein supplements in older adults with sarcopenia: A systematic review and meta-analysis of randomized controlled trials. Arch Gerontol Geriatr. 2022 Sep-Oct;102:104758. doi: 10.1016/j.archger.2022.104758. Epub 2022 Jun 24.
- Individual participant dataSharing planned: No. Due to ethical and privacy considerations, individual participant data will not be publicly available. De-identified data may be shared upon reasonable request and with approval from the institutional review board.
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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 Participants consume two sachets daily over a 12-week intervention period. in people with Low Muscle Mass and Low Muscle Strength, 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 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 8 Jan 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. 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?
Appendicular Skeletal Muscle Index (ASMI) (time frame: Baseline and 12 weeks after intervention). 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 NCT07309120, which also lists 2 linked publications.
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 8 Jan 2026.