Multi-nutrient Supplement to Improve Physical Performance in Older Adults

McGill University

Status: Completed

Conditions: Old Age

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Multi-nutrient supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT04454359

15-633-MUHC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

EXP

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Multi-nutrient supplement

CTR

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo