Clinical trial NCT04454359: Multi-nutrient Supplement to Improve Physical Performance in Older Adults
Official title: Nutritional Supplement to Improve Physical Performance in Geriatric Day Hospital Participants: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Old Age
Keywords: nutritional supplement
loss of autonomy
rehabilitation
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Réseau québécois de recherche sur le vieillissement
name: MUHC-Montreal General Hospital Foundation
First posted: 2020-07-01
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, placebo-controlled, double-blinded pilot trial
Primary purpose: OTHER

Brief summary: Geriatric Day Hospitals (GDH) of the McGill University Health Centre and l'Institut de Gériatrie de Montreal offer comprehensive rehabilitation programs including physiotherapy and medical care, but no dietetic counselling for the attending frail population at high risk of malnutrition. This study aims to implement a multi-nutrient supplement to further improve nutritional status, physical function and capacity. A whey protein, leucine, vitamin D and omega-3 fatty acid supplement ingested during 16 weeks will be tested versus an isocaloric placebo on measures of physical performance and muscle mass and strength, in GDH participants. The specific objective of this pilot-study is to test feasibility and adherence; pilot data could lead to a larger trial.

Detailed description: RATIONALE Given the high prevalence of malnutrition of the GDH participants and its impact on poor physical performance, providing a nutritional supplement to increase protein, leucine, vitamin D and omega-3 FA intake should complement and optimize the rehabilitation interventions in improving muscle mass, strength and physical performance.

OBJECTIVES

Implementing the proposed nutritional supplement in the routine care of GDH participants will:

1. test the feasibility, acceptance and adherence to the supplement and its safety
2. provide pilot data to test the superiority of the supplement versus an isocaloric placebo on measures of muscle mass, strength, and physical performance.

STUDY DESIGN. This is a randomized, placebo-controlled, double-blinded trial of two parallel arms, conducted on two sites. Eligible participants will be randomly assigned to one of two groups: experimental (EXP) or control (CTR) in a 1:1 ratio. Randomization will be achieved by computer-generated permuted block of four.

INTERVENTION The EXP arm will ingest a multi-nutrient supplement consisting of whey protein + leucine and fish oil + vitamin D and CTR arm will ingest an isocaloric plabebo, during 16 weeks (about 8 weeks during rehabilitation and 8 more weeks after). Outcome assessment will be performed at baseline, week 8 and week 16, except for body composition measured by DXA at baseline and week 16.

OUTCOMES Primary: feasibility Secondary: physical performance, muscle strength, appendicular lean mass Other: dietary intake, physical activity, clinical markers

STATISTICAL ANALYSIS This pilot study is designed to generate data on feasibility, acceptance and compliance to the supplement and is not powered for identifying statistical differences in the secondary outcomes. A sample size of n=40 (20/group) is planned to test feasibility. Data will be reported as medians and 95% CI.

Eligibility criteria: Inclusion Criteria:

* participants of Geriatric Day Hospital programs
* able to understand study requirements (Mini Mental State Exam, MMSE \>22/30)
* able to read and speak English or French

Exclusion Criteria:

* BMI \>35 kg/m2
* glomerular filtration rate \<30 mL/min/SA),
* liver or heart failure,
* stroke in the last 6 months (unless totally recovered),
* Parkinson's disease or severe neurologic conditions,
* active malignancies,
* acute inflammation (CRP \>10 mg/L),
* known diagnostic of hyperparathyroidism,
* recent acute weight loss (\>10% in 3 months, unless stabilized),
* allergy to milk and/or fish,
* long-term use of corticosteroids or anti-neoplastic medication

Primary outcomes:
measure: Feasibility: recruitment rate
timeFrame: Recruitment over 2 years
measure: Feasibility: adherence to intervention
timeFrame: Over 16 weeks
measure: Feasibility: completion
timeFrame: Over 16 weeks
Secondary outcomes:
measure: 6-minute walking test
timeFrame: Weeks 0, 8 and 16
measure: Chair stand test
timeFrame: Weeks 0, 8 and 16
measure: Timed-up-and-go test
timeFrame: Weeks 0, 8 and 16
measure: Handgrip strength
timeFrame: Weeks 0, 8 and 16
measure: Leg strength
timeFrame: Weeks 0, 8 and 16
measure: Appendicular lean mass
timeFrame: Weeks 0 and 16
Other outcomes:
measure: Protein intake
timeFrame: Weeks 0, 8 and 16
measure: Step counts
timeFrame: Weeks 0, 8 and 16
measure: Serum albumin
timeFrame: Weeks 0, 8 and 16
measure: Serum pre-albumin
timeFrame: Weeks 0, 8 and 16
measure: Serum C-reactive Protein
timeFrame: Weeks 0, 8 and 16
measure: Serum Vitamin D
timeFrame: Weeks 0, 8 and 16
measure: Plasma glucose
timeFrame: Weeks 0, 8 and 16
measure: Serum IGF-1
timeFrame: Weeks 0, 8 and 16
measure: Plasma phospholipid omega-3 fatty acids
timeFrame: Weeks 0, 8 and 16
measure: Energy intake
timeFrame: Weeks 0, 8 and 16
Locations:
Study officials:
affiliation: Research Institute of the McGill University Health Centre
name: Stéphanie Chevalier, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tessier AJ, Levy-Ndejuru J, Moyen A, Lawson M, Lamarche M, Morais JA, Bhullar A, Andriamampionona F, Mazurak VC, Chevalier S. A 16-week randomized controlled trial of a fish oil and whey protein-derived supplement to improve physical performance in older adults losing autonomy-A pilot study. PLoS One. 2021 Aug 23;16(8):e0256386. doi: 10.1371/journal.pone.0256386. eCollection 2021.