Protein Supplement and Exercise Training for the Treatment of Sarcopenia Risk in Older Adults
NCT ID: NCT05688956
Last Updated: 2025-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-02-01
2025-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Each participant will know if they are either taking the oral nutritional supplement or not. There is no placebo, ONS being provided. 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.
Study Groups
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(i) ONS + Exercise group
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.
Fortimel Advanced, Nutricia
Per 200 mL serving size: 300 kcal, 21 g whey protein, 3 g leucine \& 10 µg Vitamin D.
Resistance Exercise programme
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 advice
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.
(ii) Exercise-alone group
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.
Resistance Exercise programme
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 advice
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.
Interventions
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Fortimel Advanced, Nutricia
Per 200 mL serving size: 300 kcal, 21 g whey protein, 3 g leucine \& 10 µg Vitamin D.
Resistance Exercise programme
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 advice
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.
Eligibility Criteria
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Inclusion Criteria
* Requiring supportive homecare
* At risk of sarcopenia
Exclusion Criteria
* 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
* 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
70 Years
100 Years
ALL
No
Sponsors
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University College Dublin
OTHER
Responsible Party
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Locations
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UCD School of Public Health, Physiotherapy and Sports Science
Dublin, Leinster, Ireland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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107102
Identifier Type: -
Identifier Source: org_study_id
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