SarcopeniaNCT06173271
The Effect of a Multi-intervention Program and Protein Food Sources on Preventing and Mitigating Sarcopenia
A study testing multi-intervention program and protein foods supplementation in people with Sarcopenia and Dietary Exposure, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Sarcopenia is characterized by loss of skeletal muscle mass and strength with advancing age. It is linked to an increased risk of falls, disability, length of hospitalization, poor quality of life, and burden of health care. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Dietary Exposure, Nutrition, Healthy
- What is being tested?
- multi-intervention program and protein foods supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Dec 2022to 30 Apr 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over the age of 60 from the free-living community
Who cannot join
- Kidney patients, diabetics, cancer patients, moderate/severe cognitively impaired, disability, those who take any commercial protein nutritional supplements, those who are underweight, vegans, food allergy to dairy products and soy products
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Yi-Chen Huang
Taichung, Baseline and Post Test of Intervention, 406040
About this study
Sarcopenia is characterized by loss of skeletal muscle mass and strength with advancing age. It is linked to an increased risk of falls, disability, length of hospitalization, poor quality of life, and burden of health care. Nutrition and physical activity are the major modifiable factors to prevent and mitigate sarcopenia. However, most studies focused on the explore the effects of physical activity or single nutrient supplementation. Whether a multi-intervention program combining protein-rich food intake, nutrition education, and exercise can more effectively reduce the risk of sarcopenia still needs to be explored at the community level. This study aimed to investigate the effects of a multi-intervention program (protein-rich food supplement, nutrition education, and exercise) on reducing the risk of sarcopenia. The primary outcome is to evaluate the effect of a multi-intervention program and exercise intervention only. The second outcome is to assess the impact of animal and plant source protein on muscle mass and physical performance. Investigators will recruit the study participants over the age of 60 from the free-living community. All participants were randomized into five groups: animal protein, plant protein, exercise and nutrition education, exercise alone, and control. For 8 weeks, except for control group, all four groups receive resistance training 3 times/week. However, the animal and plant protein groups provide milk 240 mL and soy milk 230 mL (7-8 g protein/serving) after exercise, respectively, and receive personal nutritional counseling and education to adhere to dietary recommendations. Dual-energy X-Ray using to evaluate the body composition and measure the grip strength, five-time chair stand test, and gait speed to assess physical performance pre- and post-intervention. The results of this study can be used to prevent muscle mass loss and frailty for older adults in the community.
- Conditions
- Sarcopenia, Dietary Exposure, Nutrition, Healthy, Bone Health, Muscle Function, Muscle Performance
- Being tested
- multi-intervention program and protein foods supplementation
- Keywords
- sarcopenia, protein, exercise, nutritional education, bone health
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-intervention program and protein foods supplementationDietary supplement
This study aimed to investigate the effects of a multi-intervention program (protein-rich food supplement, nutrition education, and exercise) on reducing the risk of sarcopenia.
| Study group | Role | What they receive |
|---|---|---|
| Exercise only | Other | Exercise only (60 min/times, 3 times/wk) Receives: Dietary Supplement: multi-intervention program and protein foods supplementation |
| plant protein group | Active comparator | Soymilk (230ml) and sweet potato (60g) supplementation after exercise (3 times/wk) plus nutrition education (once a wk) Receives: Dietary Supplement: multi-intervention program and protein foods supplementation |
| animal protein group | Active comparator | Milk (240ml) and sweet potato (60g) supplementation after exercise (3 times/wk) plus nutrition education (once a wk) Receives: Dietary Supplement: multi-intervention program and protein foods supplementation |
| Control | No intervention | No exercise and no nutrition education intervention |
| Exercise and Nutrition Education group | Active comparator | Exercise 60 min/times and three times per week Nutrition education 30 min/week Receives: Dietary Supplement: multi-intervention program and protein foods supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of a multi-intervention program and exercise intervention on muscle mass
The changes from baseline in muscle mass will be assessed by DXA in kilogram/meter2.
Measured: From the date of the first time to collect the baseline data until the date of completion of the study (after intervention), assessed up to 12 weeks
The effect of a multi-intervention program and exercise intervention on calf circumference
The changes from baseline in calf circumference will be assessed by tape in cm
Measured: From the date of the first time to collect the baseline data until the date of completion of the study (after intervention), assessed up to 12 weeks
The effect of a multi-intervention program and exercise intervention on grip strength
The changes from baseline in grip strength will be assessed by grip meter in kg
Measured: From the date of the first time to collect the baseline data until the date of completion of the study (after intervention), assessed up to 12 weeks
The effect of a multi-intervention program and exercise intervention on walking speed
The changes from baseline in walking speed will be assessed by timer in meters/second
Measured: From the date of the first time to collect the baseline data until the date of completion of the study (after intervention), assessed up to 12 weeks
The effect of a multi-intervention program and exercise intervention on sit-to-stand speed
The changes from baseline in sit-to-stand test will be assessed by timer in second
Measured: From the date of the first time to collect the baseline data until the date of completion of the study (after intervention), assessed up to 12 weeks
Secondary outcomes (1)
The effect of a multi-intervention program and exercise intervention on dietary intake
The changes from baseline in dietary intake at 8 weeks will be assessed by questionnaire.
Measured: From the date of the first time to collect the baseline data until the date of completion of the study (after intervention), assessed up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start29 Dec 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
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.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi-Chen Huang, PhD, Principal investigator, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173271
- Sponsor's protocol ID
- CMUH111-REC2-164
- Status last verified
- Oct 2024
- First submitted
- 7 Feb 2023
- Last updated
- 9 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liao T, Wang TY, Lu MC, Kuo HL, Chen YL, Lin KC, Chen YL, Hsiao Y, Huang YC. Muscle performance and bone density following a multi-intervention program with milk or soy milk supplementation in older adults: quasi-experimental study. J Nutr Health Aging. 2026 Mar;30(3):100784. doi: 10.1016/j.jnha.2026.100784. Epub 2026 Jan 22.
PubMed 41576679
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Multi-intervention Program and Protein Food Sources on Preventing and Mitigating Sarcopenia
- ClinicalTrials.gov ID
- NCT06173271
- Acronym / sponsor ID
- CMUH111-REC2-164
- Conditions
- Sarcopenia, Dietary Exposure, Nutrition, Healthy, Bone Health, Muscle Function, Muscle Performance
- Keywords
- sarcopenia, protein, exercise, nutritional education, bone health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 29 Dec 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 15 Dec 2023 (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.
Sarcopenia is characterized by loss of skeletal muscle mass and strength with advancing age. It is linked to an increased risk of falls, disability, length of hospitalization, poor quality of life, and burden of health care. Nutrition and physical activity are the major modifiable factors to prevent and mitigate sarcopenia. However, most studies focused on the explore the effects of physical activity or single nutrient supplementation. Whether a multi-intervention program combining protein-rich food intake, nutrition education, and exercise can more effectively reduce the risk of sarcopenia still needs to be explored at the community level. This study aimed to investigate the effects of a multi-intervention program (protein-rich food supplement, nutrition education, and exercise) on reducing the risk of sarcopenia. The primary outcome is to evaluate the effect of a multi-intervention program and exercise intervention only. The second outcome is to assess the impact of animal and plant source protein on muscle mass and physical performance. Investigators will recruit the study participants over the age of 60 from the free-living community. All participants were randomized into five groups: animal protein, plant protein, exercise and nutrition education, exercise alone, and control. For 8 weeks, except for control group, all four groups receive resistance training 3 times/week. However, the animal and plant protein groups provide milk 240 mL and soy milk 230 mL (7-8 g protein/serving) after exercise, respectively, and receive personal nutritional counseling and education to adhere to dietary recommendations. Dual-energy X-Ray using to evaluate the body composition and measure the grip strength, five-time chair stand test, and gait speed to assess physical performance pre- and post-intervention. The results of this study can be used to prevent muscle mass loss and frailty for older adults in the community.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Exercise only | Other | Dietary Supplement: multi-intervention program and protein foods supplementationExercise only (60 min/times, 3 times/wk) |
| plant protein group | Active comparator | Dietary Supplement: multi-intervention program and protein foods supplementationSoymilk (230ml) and sweet potato (60g) supplementation after exercise (3 times/wk) plus nutrition education (once a wk) |
| animal protein group | Active comparator | Dietary Supplement: multi-intervention program and protein foods supplementationMilk (240ml) and sweet potato (60g) supplementation after exercise (3 times/wk) plus nutrition education (once a wk) |
| Control | No intervention | –No exercise and no nutrition education intervention |
| Exercise and Nutrition Education group | Active comparator | Dietary Supplement: multi-intervention program and protein foods supplementationExercise 60 min/times and three times per week Nutrition education 30 min/week |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- over the age of 60 from the free-living community
Key exclusion criteria (1 listed)
- Kidney patients, diabetics, cancer patients, moderate/severe cognitively impaired, disability, those who take any commercial protein nutritional supplements, those who are underweight, vegans, food allergy to dairy products and soy products
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 |
|---|---|---|
| multi-intervention program and protein foods supplementationThis study aimed to investigate the effects of a multi-intervention program (protein-rich food supplement, nutrition education, and exercise) on reducing the risk of sarcopenia. | Dietary supplement | Exercise and Nutrition Education group, Exercise only, animal protein group, plant protein group |
Primary outcome
The effect of a multi-intervention program and exercise intervention on muscle mass
Time frame: From the date of the first time to collect the baseline data until the date of completion of the study (after intervention), assessed up to 12 weeks
The changes from baseline in muscle mass will be assessed by DXA in kilogram/meter2.
The effect of a multi-intervention program and exercise intervention on calf circumference
Time frame: From the date of the first time to collect the baseline data until the date of completion of the study (after intervention), assessed up to 12 weeks
The changes from baseline in calf circumference will be assessed by tape in cm
The effect of a multi-intervention program and exercise intervention on grip strength
Time frame: From the date of the first time to collect the baseline data until the date of completion of the study (after intervention), assessed up to 12 weeks
The changes from baseline in grip strength will be assessed by grip meter in kg
The effect of a multi-intervention program and exercise intervention on walking speed
Time frame: From the date of the first time to collect the baseline data until the date of completion of the study (after intervention), assessed up to 12 weeks
The changes from baseline in walking speed will be assessed by timer in meters/second
The effect of a multi-intervention program and exercise intervention on sit-to-stand speed
Time frame: From the date of the first time to collect the baseline data until the date of completion of the study (after intervention), assessed up to 12 weeks
The changes from baseline in sit-to-stand test will be assessed by timer in second
1 secondary outcome
The effect of a multi-intervention program and exercise intervention on dietary intake
Time frame: From the date of the first time to collect the baseline data until the date of completion of the study (after intervention), assessed up to 12 weeks
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 9 Oct 2024.
- Derived from this study: PubMed 41576679Liao T, Wang TY, Lu MC, Kuo HL, Chen YL, Lin KC, Chen YL, Hsiao Y, Huang YC. Muscle performance and bone density following a multi-intervention program with milk or soy milk supplementation in older adults: quasi-experimental study. J Nutr Health Aging. 2026 Mar;30(3):100784. doi: 10.1016/j.jnha.2026.100784. Epub 2026 Jan 22.
Related trials for Sarcopenia
Active, not recruitingObservational study
Possible Sarcopenia, Sarcopenia, and Functional Status in Patients With Primary Sjögren's Syndrome
Primary Sjögren Syndrome, Sarcopenia
Not yet recruiting
PROfiles of FGF-19 Post-prandial Secretion in Older Adults With Frailty and Without Frailty
Frailty, Sarcopenia
Recruiting
Resistance vs Aerobic Prehabilitation Before Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Neoplasms
Recruiting
Effects of a Community-based Multicomponent Physical Exercise Program on Physical Function, Frailty, and Sarcopenia in Older Adults From the Municipality of Santoña: a Quasi-experimental Study.
Frailty/Sarcopenia, Frailty in Older Adults
Not yet recruiting
Creatine and Muscle Health in Madrid's Walking Footballers.
Muscle Adaptation, Body Composition
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.
Yi-Chen Huang, PhD principal investigator
China Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multi-intervention program and protein foods supplementation in people with Sarcopenia and Dietary Exposure, run by China Medical 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 1 inclusion and 1 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 9 Oct 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 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?
The effect of a multi-intervention program and exercise intervention on muscle mass (time frame: From the date of the first time to collect the baseline data until the date of completion of the study (after intervention), assessed up to 12 weeks). The study lists 5 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 NCT06173271, 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 9 Oct 2024.