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

Primary Purpose

Sarcopenia, Malnutrition

Status
Recruiting
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Fortimel Advanced, Nutricia
Resistance Exercise programme
Dietary advice
Sponsored by
University College Dublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring Older adults, Homecare, Community-dwelling, Malnutrition, Sarcopenia, Oral Nutritional Supplement, Resistance exercise

Eligibility Criteria

70 Years - 100 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCD School of Public Health, Physiotherapy and Sports ScienceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

(i) ONS + Exercise group

(ii) Exercise-alone group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Recruitment
The number of participants recruited at the end of the study
Retention
The number of participants retained at the end of the study
Adherence
Attendance at the resistance exercise classes + consumption of the protein supplement
Muscle mass
Muscle mass will be assessed using Bioelectrical Impedance Analysis
Muscle strength
Handgrip strength will be used to assess upper-body strength
Five Times Sit-To-Stand test
Five Times Sit-To-Stand test will be used to assess lower extremity strength
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
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
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.
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.
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.
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.

Full Information

First Posted
December 14, 2022
Last Updated
February 20, 2023
Sponsor
University College Dublin
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1. Study Identification

Unique Protocol Identification Number
NCT05688956
Brief Title
Protein Supplement and Exercise Training for the Treatment of Malnutrition and Sarcopenia Risk in Older Adults
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College Dublin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Malnutrition
Keywords
Older adults, Homecare, Community-dwelling, Malnutrition, Sarcopenia, Oral Nutritional Supplement, Resistance exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
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.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
(i) ONS + Exercise group
Arm Type
Experimental
Arm 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.
Arm Title
(ii) Exercise-alone group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fortimel Advanced, Nutricia
Intervention Description
Per 200 mL serving size: 300 kcal, 21 g whey protein, 3 g leucine & 10 µg Vitamin D.
Intervention Type
Other
Intervention Name(s)
Resistance Exercise programme
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Dietary advice
Intervention Description
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 Outcome Measure Information:
Title
Change from Baseline Nutritional Status at 12 weeks
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Recruitment
Description
The number of participants recruited at the end of the study
Time Frame
24 weeks
Title
Retention
Description
The number of participants retained at the end of the study
Time Frame
24 weeks
Title
Adherence
Description
Attendance at the resistance exercise classes + consumption of the protein supplement
Time Frame
12 weeks
Title
Muscle mass
Description
Muscle mass will be assessed using Bioelectrical Impedance Analysis
Time Frame
12 weeks
Title
Muscle strength
Description
Handgrip strength will be used to assess upper-body strength
Time Frame
12 weeks
Title
Five Times Sit-To-Stand test
Description
Five Times Sit-To-Stand test will be used to assess lower extremity strength
Time Frame
12 weeks
Title
Timed Get Up & Go test
Description
Timed Get Up & Go test will be used to assess physical performance advised by the advised by the EWGSOP2 to test for sarcopenia
Time Frame
12 weeks
Title
4 m Gait Speed test
Description
4 m Gait Speed test will be used to assess physical performance advised by the advised by the EWGSOP2 to test for sarcopenia
Time Frame
12 weeks
Title
Change in self-reported quality of life
Description
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.
Time Frame
12 weeks
Title
Change in risk of depression
Description
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.
Time Frame
12 weeks
Title
Change in functional status
Description
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.
Time Frame
12 weeks
Title
Change in baseline nutritional status at week 24
Description
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.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Fallon, BSc
Phone
+353867240910
Email
catherine.fallon@ucdconnect.ie
First Name & Middle Initial & Last Name or Official Title & Degree
Clare Corish, PhD
Email
clare.corish@ucd.ie
Facility Information:
Facility Name
UCD School of Public Health, Physiotherapy and Sports Science
City
Dublin
State/Province
Leinster
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine M Fallon, BSc
Phone
0867240910
Email
catherine.fallon@ucdconnect.ie
First Name & Middle Initial & Last Name & Degree
Clare Corish, PhD
Email
clare.corish@ucd.ie

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.

Learn more about this trial

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

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