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

Sarcopenia Clinical Trial

— POWER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05688956
• Other study ID #: 107102
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: February 2023
• Source: University College Dublin
• Contact: Catherine Fallon, BSc
• Phone: +353867240910
• Email: catherine.fallon[@]ucdconnect.ie
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To explore the efficacy 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 homecare and are at risk of both malnutrition and sarcopenia.

Description:

The aim of this study is to investigate the efficacy of consuming a whey protein oral nutritional supplement (ONS) enriched with leucine and vitamin D, in conjunction with a resistance-based exercise programme delivered using telehealth, versus the efficacy of the exercise programme alone, for twelve weeks, in a cohort of older adults who are at risk of both malnutrition and sarcopenia and who require supportive homecare. The primary outcome will be nutritional status measured using 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 function as well as quality of life. 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 groups will be as follows: (i) whey protein ONS enriched with leucine and vitamin D plus an exercise programme delivered using telehealth or (ii) exercise programme delivered using telehealth. Participants allocated to the ONS group will be provided with the ONS, and the exercise programme will be delivered using the UCD Zoom platform. To ensure that the PhD researcher can safely manage the study participants, there will be a staggered start. Two groups (a) ONS + exercise programme and (b) exercise programme alone will begin the intervention within one month of screening, complete the 12-week intervention and be reassessed after a further 12 weeks. The other two groups (c) ONS + exercise programme and (d) exercise programme alone will be assessed at week 0 and will begin the intervention 12 to 16 weeks later. Nutritional status will be reassessed to determine if any changes to nutritional status have occurred between screening and commencing the intervention. The staggered start group will then begin the intervention and complete the intervention after twelve weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 31, 2025
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 100 Years

Eligibility

Inclusion Criteria:

• Older adults (70+ years)
• Requiring supportive homecare
• At risk of malnutrition (MNA-SF)
• At risk of sarcopenia (EWGSOP2)

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

Related Conditions & MeSH terms

• Malnutrition
• Sarcopenia

Intervention

Dietary Supplement:
• Fortimel Advanced, Nutricia
Per 200 mL serving size: 300 kcal, 21 g whey protein, 3 g leucine & 10 µg Vitamin D.

Other:
• 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.

Locations

Country	Name	City	State
Ireland	UCD School of Public Health, Physiotherapy and Sports Science	Dublin	Leinster

Sponsors (1)

Lead Sponsor	Collaborator
University College Dublin

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Nutritional Status at 12 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.	12 weeks
Secondary	Recruitment	The number of participants recruited at the end of the study	24 weeks
Secondary	Retention	The number of participants retained at the end of the study	24 weeks
Secondary	Adherence	Attendance at the resistance exercise classes + consumption of the protein supplement	12 weeks
Secondary	Muscle mass	Muscle mass will be assessed using Bioelectrical Impedance Analysis	12 weeks
Secondary	Muscle strength	Handgrip strength will be used to assess upper-body strength	12 weeks
Secondary	Five Times Sit-To-Stand test	Five Times Sit-To-Stand test will be used to assess lower extremity strength	12 weeks
Secondary	Timed Get Up & Go test	Timed Get Up & Go test will be used to assess physical performance advised by the advised by the EWGSOP2 to test for sarcopenia	12 weeks
Secondary	4 m Gait Speed test	4 m Gait Speed test will be used to assess physical performance advised by the advised by the EWGSOP2 to test for sarcopenia	12 weeks
Secondary	Change in self-reported quality of life	The Health Related Quality of Life 12-Item Short Form Survey (SF-12) will be used to assess participants quality of life. Score ranges from 0 - 100, higher score indicates higher quality of life.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	24 weeks