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

Sponsor

University College Dublin (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05688956

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sarcopenia Malnutrition	Dietary Supplement: Fortimel Advanced, Nutricia Other: Resistance Exercise programme Other: Dietary advice	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Participant)

Masking Description:

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.

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Aug 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: (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.	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. Other: 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.
Active Comparator: (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.	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. Other: 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.

Arm

Intervention/Treatment

Experimental: (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.

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.

Other: 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.

Active Comparator: (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.

Other: Resistance Exercise programme

Other: Dietary advice

Outcome Measures

Primary Outcome Measures

Change from Baseline Nutritional Status at 12 weeks [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.

Secondary Outcome Measures

Recruitment [24 weeks]
The number of participants recruited at the end of the study
Retention [24 weeks]
The number of participants retained at the end of the study
Adherence [12 weeks]
Attendance at the resistance exercise classes + consumption of the protein supplement
Change in muscle mass [12 weeks]
Muscle mass will be assessed using Bioelectrical Impedance Analysis
Change in muscle strength [12 weeks]
Handgrip strength will be used to assess upper-body strength
Change in muscle strength [12 weeks]
Five Times Sit-To-Stand test will be used to assess lower extremity strength
Change in physical performance [12 weeks]
Timed Get Up & Go test will be used to assess physical performance advised by the advised by the EWGSOP2 to test for sarcopenia
Change in physical performance [12 weeks]
4 m Gait Speed test will be used to assess physical performance advised by the advised by the EWGSOP2 to test for sarcopenia
Change in self-reported quality of life [12 weeks]
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.
Change in risk of depression [12 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.
Change in functional status [12 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.
Change in baseline nutritional status at week 24 [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.