SarcopeniaPOWERNCT05688956
Protein Supplement and Exercise Training for the Treatment of Sarcopenia Risk in Older Adults
A study testing Fortimel Advanced, Nutricia, Resistance Exercise programme and Dietary advice in people with Sarcopenia, run by University College Dublin at 1 site in Ireland.
Trial summary
To explore the effectiveness of a 12-week resistance exercise programme plus or minus an oral nutritional supplement on the nutritional status of community-dwelling older adults who receive home care and are at risk of sarcopenia. Read more about this study
- Who is it for?
- Ages 70 to 100 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Fortimel Advanced, Nutricia, Resistance Exercise programme and Dietary advice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteIreland
- Study dates
- 1 Feb 2023to 31 May 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 70 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Older adults (70+ years)
- Requiring supportive homecare
- At risk of sarcopenia
Who cannot join
- Cognitive impairment
- Severe kidney disease (glomerular filtration rate < 30 mL/min)
- Moderate to severe liver disease (Child-Pugh class B or C)
- Psychiatric disorder
- Receiving treatment or palliative care for cancer
- Receiving enteral or parenteral nutrition
Show all 11Show fewer
- Hypersensitivity to any component of ONS
- Taking ONS
- Allergic to dairy products
- Regularly undertaking resistance (strength) training
- Advised by GP not to undertake physical activity
Trial locations and contacts
1 site in 1 country.
Ireland1 site
UCD School of Public Health, Physiotherapy and Sports Science
Dublin, Leinster
About this study
Official title: Protein Supplement and Exercise Training for the Treatment of Sarcopenia Risk in Older Adults Who Receive Supportive Home Care: POWER Study
To explore the effectiveness of a 12-week resistance exercise programme plus or minus an oral nutritional supplement on the nutritional status of community-dwelling older adults who receive home care and are at risk of sarcopenia.
Read the detailed description
The aim of this study is to investigate the effectiveness of consuming a whey-based protein ONS enriched with leucine and vitamin D, in conjunction with an online resistance-based exercise programme, versus the effectiveness of an online exercise programme alone, for twelve weeks, in a cohort of older adults who are at risk of sarcopenia and who require supportive home care.
The primary outcome will be functional and nutritional status measured using the Timed get Up and Go (TUG) test and the full form of the mini-nutritional assessment (MNA-FF). The secondary outcomes include feasibility of implementation, defined by recruitment, retention and adherence rates, measures of body composition, muscle strength and quality of life.
The groups will be as follows: (i) whey protein ONS enriched with leucine and vitamin D plus an online exercise programme or (ii) an online exercise programme alone.
The exercise programme will be comprised of two sessions per week for 12-weeks and will be delivered using the UCD Zoom platform. The exercise programme will include strength movements that are intended to build muscle mass and improve physical function. The exercise programme will involve four phases split over the 12-week intervention: phase 1 (2 weeks), phase 2 (3 weeks), phase 3 (3 weeks) and phase 4 (4 weeks).
The ONS is a high protein, leucine and vitamin D enriched drink. Participants randomised to the ONS group will be asked to consume the drink twice a day for 12 weeks.
- Conditions
- Sarcopenia
- Being tested
- Fortimel Advanced, Nutricia, Resistance Exercise programme, Dietary advice
- Keywords
- Older adults, Home care, Community-dwelling, Sarcopenia, Oral Nutritional Supplement, Resistance exercise
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortimel Advanced, NutriciaDietary supplement
Per 200 mL serving size: 300 kcal, 21 g whey protein, 3 g leucine \& 10 µg Vitamin D.
Resistance Exercise programmeOther
Participants will participate in the resistance-based exercise programme twice a week for 12-weeks via Zoom. Each session will last between 45-60 minutes with 2-3 sets and 8-12 reps, twice a week for the 12 weeks.
Dietary adviceOther
Standard dietary advice to increase intake of protein, leucine and vitamin D using available literature designed for those at risk of malnutrition will be provided to both groups by the research nutritionist. Literature provided will include booklets containing lists of foods high in protein, leucine and vitamin D plus easy-to-prepare meal ideas. The dietary advice provided will be informed by the 24-hour dietary recall information obtained from each participant.
| Study group | Role | What they receive |
|---|---|---|
| (i) ONS + Exercise group | Experimental | This group will consume whey protein ONS enriched with leucine and vitamin D, twice a day for 12 weeks. The optimal time to consume the ONS on non-exercise days will be based on each participants 24-hour dietary recall. On exercise days, participants will be asked to consume the ONS after breakfast and after the exercise class. Participants will participate in a resistance-based exercise programme twice a week for 12 weeks which will be carried out over Zoom. Standard dietary advice to increase intake of protein, leucine and vitamin D using available literature designed for those at risk of malnutrition will be provided to this group by the research nutritionist. Receives: Dietary Supplement: Fortimel Advanced, Nutricia; Other: Resistance Exercise programme; Other: Dietary advice |
| (ii) Exercise-alone group | Active comparator | Participants will participate in a resistance-based exercise programme twice a week for 12 weeks which will be carried out over Zoom. Standard dietary advice to increase intake of protein, leucine and vitamin D using available literature designed for those at risk of malnutrition will be provided to this group by the research nutritionist. The participants will not be provided with a placebo ONS. Receives: Other: Resistance Exercise programme; Other: Dietary advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline functional status at 12 weeks
Timed Get Up \& Go test will be used to assess physical performance as advised by the EWGSOP2 to test for sarcopenia.
Measured: 12 weeks
Change from baseline nutritional status at 12 weeks
The nutritional status of participants will be assessed using the full form of the mini-nutritional assessment-full form (MNA-FF). 24 - 30 points indicates normal nutrition status; 17 to 23.5 points indicates at risk of malnutrition \& less than 17 points indicates malnutrition.
Measured: 12 weeks
Secondary outcomes (12)
Adherence
Attendance at the resistance exercise classes + consumption of the protein supplement
Measured: 12 weeks
Muscle mass
Muscle mass will be assessed using Bioelectrical Impedance Analysis
Measured: Values at baseline will be compared to values recorded at 12 and at 24 weeks
Muscle strength
Handgrip strength will be used to assess upper-body strength
Measured: Values at baseline will be compared to values recorded at 12 and at 24 weeks
Five Times Sit-To-Stand test
Five Times Sit-To-Stand test will be used to assess lower extremity strength
Measured: Values at baseline will be compared to values recorded at 12 and at 24 weeks
4 m Gait Speed test
4 m Gait Speed test will be used to assess physical performance as advised by the EWGSOP2 to test for sarcopenia
Measured: Values at baseline will be compared to values recorded at 12 and at 24 weeks
Change in self-reported quality of life
The Health Related Quality of Life 12-Item Short Form Survey (SF-12v2) will be used to assess participants quality of life. Score ranges from 0 - 100, higher score indicates higher quality of life.
Measured: Values at baseline will be compared to values recorded at 12 and at 24 weeks
Change in risk of depression
The Geriatric Depression Score-15 item questionnaire will be used to screen for risk of depression in the participants. Score of 0-5 is normal \& score greater than 5 suggests risk of depression.
Measured: Values at baseline will be compared to values recorded at 12 and at 24 weeks
Change in functional status
The Katz Index of Independence in Activities of Daily Living will be used to assess functional status. Score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.
Measured: Values at baseline will be compared to values recorded at 12 and at 24 weeks
Change in baseline nutritional status at week 24
The nutritional status of participants will assessed using the full form of the mini-nutritional assessment-full form (MNA-FF). 24 - 30 points indicates normal nutrition status, 17 to 23.5 points indicates at risk of malnutrition \& less than 17 points indicates malnutrition.
Measured: 24 weeks
Change from baseline functional status at 24 weeks
Timed Get Up \& Go test will be used to assess physical performance as advised by the EWGSOP2 to test for sarcopenia.
Measured: 24 weeks
Retention
The number of participants retained at the end of the study
Measured: Up to 24 weeks
Recruitment
The number of participants recruited divided by the number of eligible participants.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Feb 2023
- Primary completion31 May 2025
- Study completion31 May 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.
- 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
- Model description
- A randomised, parallel group, 12-week clinical trial with two groups of older adults aged 70+ years requiring supportive home care will be undertaken.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688956
- Sponsor's protocol ID
- 107102
- Acronym
- POWER
- Status last verified
- Jan 2025
- First submitted
- 14 Dec 2022
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Fallon CM, Cunningham CG, Horner K, Corish CA. Oral nutritional supplement combined with an online resistance training programme to improve physical function and nutritional status in older adults receiving home care and at risk of sarcopenia: protocol for the randomised controlled POWER trial. HRB Open Res. 2026 Jan 20;8:41. doi: 10.12688/hrbopenres.14086.3. eCollection 2025.
PubMed 41467085
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein Supplement and Exercise Training for the Treatment of Sarcopenia Risk in Older Adults Who Receive Supportive Home Care: POWER Study
- ClinicalTrials.gov ID
- NCT05688956
- Acronym / sponsor ID
- POWER / 107102
- Conditions
- Sarcopenia
- Keywords
- Older adults, Home care, Community-dwelling, Sarcopenia, Oral Nutritional Supplement, Resistance exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 18 Jan 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.
To explore the effectiveness of a 12-week resistance exercise programme plus or minus an oral nutritional supplement on the nutritional status of community-dwelling older adults who receive home care and are at risk of sarcopenia.
Detailed description
The aim of this study is to investigate the effectiveness of consuming a whey-based protein ONS enriched with leucine and vitamin D, in conjunction with an online resistance-based exercise programme, versus the effectiveness of an online exercise programme alone, for twelve weeks, in a cohort of older adults who are at risk of sarcopenia and who require supportive home care.
The primary outcome will be functional and nutritional status measured using the Timed get Up and Go (TUG) test and the full form of the mini-nutritional assessment (MNA-FF). The secondary outcomes include feasibility of implementation, defined by recruitment, retention and adherence rates, measures of body composition, muscle strength and quality of life.
The groups will be as follows: (i) whey protein ONS enriched with leucine and vitamin D plus an online exercise programme or (ii) an online exercise programme alone.
The exercise programme will be comprised of two sessions per week for 12-weeks and will be delivered using the UCD Zoom platform. The exercise programme will include strength movements that are intended to build muscle mass and improve physical function. The exercise programme will involve four phases split over the 12-week intervention: phase 1 (2 weeks), phase 2 (3 weeks), phase 3 (3 weeks) and phase 4 (4 weeks).
The ONS is a high protein, leucine and vitamin D enriched drink. Participants randomised to the ONS group will be asked to consume the drink twice a day for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomised, parallel group, 12-week clinical trial with two groups of older adults aged 70+ years requiring supportive home care will be undertaken.
| Arm | Type | Receives |
|---|---|---|
| (i) ONS + Exercise group | Experimental | Dietary Supplement: Fortimel Advanced, Nutricia, Other: Resistance Exercise programme, Other: Dietary adviceThis group will consume whey protein ONS enriched with leucine and vitamin D, twice a day for 12 weeks. The optimal time to consume the ONS on non-exercise days will be based on each participants 24-hour dietary recall. On exercise days, participants will be asked to consume the ONS after breakfast and after the exercise class. Participants will participate in a resistance-based exercise programme twice a week for 12 weeks which will be carried out over Zoom. Standard dietary advice to increase intake of protein, leucine and vitamin D using available literature designed for those at risk of malnutrition will be provided to this group by the research nutritionist. |
| (ii) Exercise-alone group | Active comparator | Other: Resistance Exercise programme, Other: Dietary adviceParticipants will participate in a resistance-based exercise programme twice a week for 12 weeks which will be carried out over Zoom. Standard dietary advice to increase intake of protein, leucine and vitamin D using available literature designed for those at risk of malnutrition will be provided to this group by the research nutritionist. The participants will not be provided with a placebo ONS. |
Who may qualify
- Ages
- 70 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Older adults (70+ years)
- Requiring supportive homecare
- At risk of sarcopenia
Key exclusion criteria (11 listed)
- Cognitive impairment
- Severe kidney disease (glomerular filtration rate < 30 mL/min)
- Moderate to severe liver disease (Child-Pugh class B or C)
- Psychiatric disorder
- Receiving treatment or palliative care for cancer
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 |
|---|---|---|
| Fortimel Advanced, NutriciaPer 200 mL serving size: 300 kcal, 21 g whey protein, 3 g leucine \& 10 µg Vitamin D. | Dietary supplement | (i) ONS + Exercise group |
| Resistance Exercise programmeParticipants will participate in the resistance-based exercise programme twice a week for 12-weeks via Zoom. Each session will last between 45-60 minutes with 2-3 sets and 8-12 reps, twice a week for the 12 weeks. | Other | (i) ONS + Exercise group, (ii) Exercise-alone group |
| Dietary adviceStandard dietary advice to increase intake of protein, leucine and vitamin D using available literature designed for those at risk of malnutrition will be provided to both groups by the research nutritionist. Literature provided will include booklets containing lists of foods high in protein, leucine and vitamin D plus easy-to-prepare meal ideas. The dietary advice provided will be informed by the 24-hour dietary recall information obtained from each participant. | Other | (i) ONS + Exercise group, (ii) Exercise-alone group |
Primary outcome
Change from baseline functional status at 12 weeks
Time frame: 12 weeks
Timed Get Up \& Go test will be used to assess physical performance as advised by the EWGSOP2 to test for sarcopenia.
Change from baseline nutritional status at 12 weeks
Time frame: 12 weeks
The nutritional status of participants will be assessed using the full form of the mini-nutritional assessment-full form (MNA-FF). 24 - 30 points indicates normal nutrition status; 17 to 23.5 points indicates at risk of malnutrition \& less than 17 points indicates malnutrition.
12 secondary outcomes
Adherence
Time frame: 12 weeks
Muscle mass
Time frame: Values at baseline will be compared to values recorded at 12 and at 24 weeks
Muscle strength
Time frame: Values at baseline will be compared to values recorded at 12 and at 24 weeks
Five Times Sit-To-Stand test
Time frame: Values at baseline will be compared to values recorded at 12 and at 24 weeks
4 m Gait Speed test
Time frame: Values at baseline will be compared to values recorded at 12 and at 24 weeks
Change in self-reported quality of life
Time frame: Values at baseline will be compared to values recorded at 12 and at 24 weeks
Change in risk of depression
Time frame: Values at baseline will be compared to values recorded at 12 and at 24 weeks
Change in functional status
Time frame: Values at baseline will be compared to values recorded at 12 and at 24 weeks
Change in baseline nutritional status at week 24
Time frame: 24 weeks
Change from baseline functional status at 24 weeks
Time frame: 24 weeks
Retention
Time frame: Up to 24 weeks
Recruitment
Time frame: Up to 24 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 17 Mar 2026.
- Derived from this study: PubMed 41467085Fallon CM, Cunningham CG, Horner K, Corish CA. Oral nutritional supplement combined with an online resistance training programme to improve physical function and nutritional status in older adults receiving home care and at risk of sarcopenia: protocol for the randomised controlled POWER trial. HRB Open Res. 2026 Jan 20;8:41. doi: 10.12688/hrbopenres.14086.3. eCollection 2025.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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 Fortimel Advanced, Nutricia, Resistance Exercise programme and Dietary advice in people with Sarcopenia, run by University College Dublin at 1 site in Ireland.
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 3 inclusion and 11 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 17 Mar 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 Ireland. 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?
Change from baseline functional status at 12 weeks (time frame: 12 weeks). The study lists 2 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 NCT05688956, 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 17 Mar 2026.