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

NCT05688956 | Completed

• 1 other identifier: 107102
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcopenia

Keywords

Older adults; Home care; Community-dwelling; Sarcopenia; Oral Nutritional Supplement; Resistance exercise

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 weeks

Secondary Outcomes (12)

• Adherence

  12 weeks

• Muscle mass

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

• Muscle strength

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

• Five Times Sit-To-Stand test

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

• 4 m Gait Speed test

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

Study Arms (2)

(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.

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.

Other: Resistance Exercise programme; Other: Dietary advice

Interventions

Fortimel Advanced, Nutricia DIETARY_SUPPLEMENT

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

(i) ONS + Exercise group

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.

(i) ONS + Exercise group; (ii) Exercise-alone group

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.

(i) ONS + Exercise group; (ii) Exercise-alone group

Eligibility Criteria

• Age: 70 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College Dublin: lead

Study Sites (1)

UCD School of Public Health, Physiotherapy and Sports Science

Dublin, Leinster, Ireland

Location

Related Publications (1)

• 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.

  PMID: 41467085 DERIVED

MeSH Terms

Conditions

Sarcopenia

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be randomly assigned to either consume the oral nutritional supplement or not. 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomised, parallel group, 12-week clinical trial with two groups of older adults aged 70+ years requiring supportive home care will be undertaken.

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: January 18, 2023
• Study Start: February 1, 2023
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: March 17, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)