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Protein Supplement and Exercise Training for the Treatment of Sarcopenia Risk in Older Adults (POWER)

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University College Dublin

Status

Enrolling

Conditions

Sarcopenia

Treatments

Other: Dietary advice
Other: Resistance Exercise programme
Dietary Supplement: Fortimel Advanced, Nutricia

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

70 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Older adults (70+ years)
  • Requiring supportive homecare
  • At risk of sarcopenia

Exclusion criteria

  • 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
  • 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

(i) ONS + Exercise group
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Fortimel Advanced, Nutricia
Other: Resistance Exercise programme
Other: Dietary advice
(ii) Exercise-alone group
Active Comparator group
Description:
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.
Treatment:
Other: Resistance Exercise programme
Other: Dietary advice

Trial contacts and locations

1

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Central trial contact

Clare Corish, PhD; Catherine Fallon, BSc

Data sourced from clinicaltrials.gov

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