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Completed

NCT Number: NCT05688956

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

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

70 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCD School of Public Health, Physiotherapy and Sports Science

Dublin, Leinster, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fortimel Advanced, Nutricia

Dietary Supplement

Per 200 mL serving size: 300 kcal, 21 g whey protein, 3 g leucine & 10 µg Vitamin D.

Resistance exercise programme

Other

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

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Adherence

    Time frame: 12 weeks

    Attendance at the resistance exercise classes + consumption of the protein supplement

  2. Muscle mass

    Time frame: Values at baseline will be compared to values recorded at 12 and at 24 weeks

    Muscle mass will be assessed using Bioelectrical Impedance Analysis

  3. Muscle strength

    Time frame: Values at baseline will be compared to values recorded at 12 and at 24 weeks

    Handgrip strength will be used to assess upper-body strength

  4. Five Times Sit-To-Stand test

    Time frame: Values at baseline will be compared to values recorded at 12 and at 24 weeks

    Five Times Sit-To-Stand test will be used to assess lower extremity strength

  5. 4 m Gait Speed test

    Time frame: Values at baseline will be compared to values recorded at 12 and at 24 weeks

    4 m Gait Speed test will be used to assess physical performance as advised by the EWGSOP2 to test for sarcopenia

  6. Change in self-reported quality of life

    Time frame: Values at baseline will be compared to values recorded at 12 and at 24 weeks

    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.

  7. Change in risk of depression

    Time frame: Values at baseline will be compared to values recorded at 12 and at 24 weeks

    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.

  8. Change in functional status

    Time frame: Values at baseline will be compared to values recorded at 12 and at 24 weeks

    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.

  9. Change in baseline nutritional status at week 24

    Time frame: 24 weeks

    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.

  10. Change from baseline functional status at 24 weeks

    Time frame: 24 weeks

    Timed Get Up & Go test will be used to assess physical performance as advised by the EWGSOP2 to test for sarcopenia.

  11. Retention

    Time frame: Up to 24 weeks

    The number of participants retained at the end of the study

  12. Recruitment

    Time frame: Up to 24 weeks

    The number of participants recruited divided by the number of eligible participants.

Sponsors and collaborators

Lead sponsor

University College Dublin

Other

Registry information

Official study title

Protein Supplement and Exercise Training for the Treatment of Sarcopenia Risk in Older Adults Who Receive Supportive Home Care: POWER Study

Acronym: POWER

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 18, 2023
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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