SarcopeniaManoPoNCT05953116
Managing the Nutritional Needs of Older Filipino With Due Attention to Protein Nutrition and Functional Health Study
A study testing Nutrition supplementation and Exercise in people with Sarcopenia, run by Food and Nutrition Research Institute, Philippines at 1 site in Philippines.
Trial summary
The study aims to determine the effect of protein nutrition and exercise on the body composition and functional capacity of Filipino older adults. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Nutrition supplementation and Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 sitePhilippines
- Study dates
- 4 Sep 2023to 30 Sep 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
- Pre-sarcopenia/pre-frail
- Aged 60 years old and above, male or female
- Free-living in the community, ambulatory
- Able to respond to food recall/interview as self-declared
- Normal cardiac function as measured by resting ECG
Who cannot join
- Bed ridden, unable to perform exercise independently
- Presence of serious medical condition (i.e. cancer, existing fracture)
- Presence of unmanaged hypertension and/or type 2 diabetes or upon assessment of physician
- Renal Problem
- Under controlled or medically-supervised diet not flexible to include the intervention agent
- Allergic to any ingredients in the nutrition supplementation
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Department of Science and Technology-Food and Nutrition Research Institute
City of Taguig, National Capital Region, 1631
About this study
Official title: Managing the Nutritional Needs of Older Filipino With Due Attention to Protein Nutrition and Functional Health (ManoPo) Study
The study aims to determine the effect of protein nutrition and exercise on the body composition and functional capacity of Filipino older adults.
Read the detailed description
The objective of the study is to determine the effects of nutrition supplementation and exercise intervention on the main indicators of sarcopenia in older adults such as body composition (fat mass and lean mass), muscle strength (leg and handgrip), and physical performance.
- Conditions
- Sarcopenia
- Being tested
- Nutrition supplementation, Exercise
- Keywords
- Sarcopenia, Body Composition, Protein, Exercise, Functional Status
- 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.
Nutrition supplementationDietary supplement
Also called Protein drink
Blinded researchers will provide the randomly assigned supplement product to the trial participants for a period of 90 days. Used packaging will be collected at the end of every week from each trial participant to monitor compliance.
ExerciseOther
Also called Resistance and group exercise
Trained researchers will facilitate resistance-based exercises two to three times a week in an enclosed venue (gym). Trial participants will be assessed at baseline for one repetition maximum (1RM) which will serve as a basis for load progression. A target of 3 sets and 6-15 repetitions with at least 30 seconds rest in between sets will be performed by the trial participants under supervision of a trained researcher.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | A protein product (combination of whey protein and plant-derived protein) in powdered form with flavoring. Product will be added to 180-200 mL of warm water prior to consumption. Receives: Dietary Supplement: Nutrition supplementation; Other: Exercise |
| Placebo Group | Placebo comparator | An isocaloric product (made with maltodextrin) in powdered form with flavoring. Product will be added to 180-200 mL of warm water prior to consumption. Receives: Dietary Supplement: Nutrition supplementation; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle mass, as measured by dual-energy x-ray absorptiometry (DXA)
Measurement of appendicular skeletal muscle mass index (ASMI) by dividing total muscle mass (kg) of appendages with height in meters squared
Measured: Baseline, Midline (6 weeks), Endline (12 weeks)
Change in muscle strength, as measured by grip strength and leg strength (Jamar, MicroFET)
Handgrip strength is measured using a hydraulic hand dynamometer through maximum exertion of grip force (in kilograms).
Leg strength is measured using a hand-held dynamometer. Participant will use strongest leg force to push against the resistance brought upon by the researcher while holding the measuring device.
Measured: Baseline, Midline (6 weeks), Endline (12 weeks)
Change in physical performance, as measured by timed up-and-go test
Faster time duration to complete the test indicate lesser risk for falls
Measured: Baseline, Midline (6 weeks), Endline (12 weeks)
Change in physical performance, as measured by short physical performance battery
Score ranges from 0 to 12 with a higher score indicating better functionality
Measured: Baseline, Midline (6 weeks), Endline (12 weeks)
Change in physical performance, as measured by 10-meter walk test
Faster walking speed (in meters per second) indicate better functionality
Measured: Baseline, Midline (6 weeks), Endline (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start4 Sep 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Food and Nutrition Research Institute, Philippines
- Sponsor type
- Other government
- Collaborators
- Wageningen University and Research
- Responsible party
- Principal investigator, Robby Carlo A. Tan, Food and Nutrition Research Institute, Philippines
- Investigators
- Robby Carlo A Tan, Msc, Principal investigator, Department of Science and Technology-Food and Nutrition Research Institute (DOST-FNRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953116
- Sponsor's protocol ID
- FIERC-2022-019
- Acronym
- ManoPo
- Status last verified
- Mar 2025
- First submitted
- 12 Jul 2023
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing the Nutritional Needs of Older Filipino With Due Attention to Protein Nutrition and Functional Health (ManoPo) Study
- ClinicalTrials.gov ID
- NCT05953116
- Acronym / sponsor ID
- ManoPo / FIERC-2022-019
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, Body Composition, Protein, Exercise, Functional Status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Food and Nutrition Research Institute, PhilippinesOther government
- Collaborators
- Wageningen University and Research
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 19 Jul 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.
The study aims to determine the effect of protein nutrition and exercise on the body composition and functional capacity of Filipino older adults.
Detailed description
The objective of the study is to determine the effects of nutrition supplementation and exercise intervention on the main indicators of sarcopenia in older adults such as body composition (fat mass and lean mass), muscle strength (leg and handgrip), and physical performance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Dietary Supplement: Nutrition supplementation, Other: ExerciseA protein product (combination of whey protein and plant-derived protein) in powdered form with flavoring. Product will be added to 180-200 mL of warm water prior to consumption. |
| Placebo Group | Placebo comparator | Dietary Supplement: Nutrition supplementation, Other: ExerciseAn isocaloric product (made with maltodextrin) in powdered form with flavoring. Product will be added to 180-200 mL of warm water prior to consumption. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pre-sarcopenia/pre-frail
- Aged 60 years old and above, male or female
- Free-living in the community, ambulatory
- Able to respond to food recall/interview as self-declared
- Normal cardiac function as measured by resting ECG
Key exclusion criteria (6 listed)
- Bed ridden, unable to perform exercise independently
- Presence of serious medical condition (i.e. cancer, existing fracture)
- Presence of unmanaged hypertension and/or type 2 diabetes or upon assessment of physician
- Renal Problem
- Under controlled or medically-supervised diet not flexible to include the intervention agent
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 |
|---|---|---|
| Nutrition supplementationAlso: Protein drinkBlinded researchers will provide the randomly assigned supplement product to the trial participants for a period of 90 days. Used packaging will be collected at the end of every week from each trial participant to monitor compliance. | Dietary supplement | Intervention Group, Placebo Group |
| ExerciseAlso: Resistance and group exerciseTrained researchers will facilitate resistance-based exercises two to three times a week in an enclosed venue (gym). Trial participants will be assessed at baseline for one repetition maximum (1RM) which will serve as a basis for load progression. A target of 3 sets and 6-15 repetitions with at least 30 seconds rest in between sets will be performed by the trial participants under supervision of a trained researcher. | Other | Intervention Group, Placebo Group |
Primary outcome
Change in muscle mass, as measured by dual-energy x-ray absorptiometry (DXA)
Time frame: Baseline, Midline (6 weeks), Endline (12 weeks)
Measurement of appendicular skeletal muscle mass index (ASMI) by dividing total muscle mass (kg) of appendages with height in meters squared
Change in muscle strength, as measured by grip strength and leg strength (Jamar, MicroFET)
Time frame: Baseline, Midline (6 weeks), Endline (12 weeks)
Handgrip strength is measured using a hydraulic hand dynamometer through maximum exertion of grip force (in kilograms). Leg strength is measured using a hand-held dynamometer. Participant will use strongest leg force to push against the resistance brought upon by the researcher while holding the measuring device.
Change in physical performance, as measured by timed up-and-go test
Time frame: Baseline, Midline (6 weeks), Endline (12 weeks)
Faster time duration to complete the test indicate lesser risk for falls
Change in physical performance, as measured by short physical performance battery
Time frame: Baseline, Midline (6 weeks), Endline (12 weeks)
Score ranges from 0 to 12 with a higher score indicating better functionality
Change in physical performance, as measured by 10-meter walk test
Time frame: Baseline, Midline (6 weeks), Endline (12 weeks)
Faster walking speed (in meters per second) indicate better functionality
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 11 Mar 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. This study is not recruiting at the moment.
Robby Carlo A Tan, Msc principal investigator
Department of Science and Technology-Food and Nutrition Research Institute (DOST-FNRI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition supplementation and Exercise in people with Sarcopenia, run by Food and Nutrition Research Institute, Philippines at 1 site in Philippines.
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 5 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: finished, as of the sponsor's last update on 11 Mar 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 Philippines. 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?
Change in muscle mass, as measured by dual-energy x-ray absorptiometry (DXA) (time frame: Baseline, Midline (6 weeks), Endline (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?
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 11 Mar 2025.