Multi-nutrient Supplement to Improve Physical Performance in Older Adults

Nutritional Supplement to Improve Physical Performance in Geriatric Day Hospital Participants: a Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Old Age
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Multi-nutrient supplement

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Dietary supplement: Multi-nutrient supplement
PLACEBO_COMPARATOR: 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.	Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: recruitment rate	Recruitment rate (measured in %, compared to expected rates)	Recruitment over 2 years
Feasibility: adherence to intervention	Adherence to supplements (measured in %, compared to expected rates)	Over 16 weeks
Feasibility: completion	Completion of study outcome assessments (measured in %, compared to expected rates)	Over 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-minute walking test	6-minute walking test (measured as the distance walked during 6 minutes, along a 30-m corridor, expressed in m)	Weeks 0, 8 and 16
Chair stand test	30-second chair stand test: measured as the number of stands from a chair without arms, in 30 sec)	Weeks 0, 8 and 16
Timed-up-and-go test	Timed-up-and-go (time to get up from a chair without armrest, walk 3 m and return to sit down completely on the chair, measured in seconds)	Weeks 0, 8 and 16
Handgrip strength	Maximal handgrip strength (using hand-held Jamar dynamometer, measured in kg),	Weeks 0, 8 and 16
Leg strength	Isometric knee extension peak torque (using Biodex, measured in N)	Weeks 0, 8 and 16
Appendicular lean mass	Sum of soft lean mass from arms and legs (measured by iDXA, in kg)	Weeks 0 and 16

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protein intake	Protein intake (g) from foods and supplements, estimated from 3-day food diary (using Food Processor with Canadian Nutrient File)	Weeks 0, 8 and 16
Step counts	Measured by accelerometry during 4 days (Actigraph)	Weeks 0, 8 and 16
Serum albumin	Albumin, in g/L (measured by the MUHC biochemical laboratory)	Weeks 0, 8 and 16
Serum pre-albumin	Pre-albumin, in mg/L (measured by the MUHC biochemical laboratory)	Weeks 0, 8 and 16
Serum C-reactive Protein	CRP, in mg/L (measured by the MUHC biochemical laboratory)	Weeks 0, 8 and 16
Serum Vitamin D	Vitamin D status, 25(OH)D, in nmol/L (measured by the MUHC biochemical laboratory)	Weeks 0, 8 and 16
Plasma glucose	Glucose, in mmol/L (measured with glucose oxidase method)	Weeks 0, 8 and 16
Serum IGF-1	IGF-1, in ng/mL (measured by ELISA)	Weeks 0, 8 and 16
Plasma phospholipid omega-3 fatty acids	EPA and DHA, expressed as a proportion (%) over total; used as an objective measure of adherence to fish oil supplement (measured by gas chromatography-flame ionization)	Weeks 0, 8 and 16
Energy intake	energy intake (kcal) from average of 3-day food diary (using Food Processor with Canadian Nutrient File)	Weeks 0, 8 and 16

Collaborators and Investigators

• Sponsor: McGill University
• Collaborators: Réseau québécois de recherche sur le vieillissement; MUHC-Montreal General Hospital Foundation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 10, 2016
• Primary Completion (ACTUAL): August 31, 2018
• Study Completion (ACTUAL): March 10, 2020

Study Registration Dates

• First Submitted: June 25, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (ACTUAL): July 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 1, 2020
• Last Update Submitted That Met QC Criteria: June 30, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: rehabilitation; nutritional supplement; loss of autonomy
• Other Study ID Numbers: 15-633-MUHC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD sharing was not planned originally and therefore consent was not obtained for it.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No