Multi-nutrient Supplement to Improve Physical Performance in Older Adults

NCT ID: NCT04454359

Last Updated: 2020-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-10
• Study Completion Date: 2020-03-10

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.

Conditions

Old Age

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

EXP

EXP group will ingest a supplement consisting of 1) flavored whey protein isolate with added pure leucine (3 g) diluted in water, twice daily, before breakfast and before bedtime; doses are adjusted per body weight as follows: 20 g, 25 g or 30 g per category of \<65 kg, 65-75 kg and \>75 kg of body weight respectively. 2) fish oil containing vitamin D, provided as 7.5 mL liquid oil providing 1500 IU vitamin D3 + 1125 mg EPA + 750 mg DHA, to be ingested once daily.

Group Type: EXPERIMENTAL

Multi-nutrient supplement

Intervention Type: DIETARY_SUPPLEMENT

CTR

Control will ingest an isocaloric placebo consisting of 1) 30 g maltodextrin, twice daily, following the same schedule, and 2) 7.5 mL corn oil, once daily.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Multi-nutrient supplement

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Réseau québécois de recherche sur le vieillissement

UNKNOWN

Sponsor Role: collaborator

MUHC-Montreal General Hospital Foundation

UNKNOWN

Sponsor Role: collaborator

McGill University

OTHER

Sponsor Role: lead

Responsible Party

Stéphanie Chevalier

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stéphanie Chevalier, PhD

Role: PRINCIPAL_INVESTIGATOR

Research Institute of the McGill University Health Centre

References

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.

Reference Type: DERIVED

PMID: 34424934 (View on PubMed)

Other Identifiers

15-633-MUHC

Identifier Type: -

Identifier Source: org_study_id