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Completed

NCT Number: NCT04454359

Multi-nutrient Supplement to Improve Physical Performance in Older Adults

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.

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Key information

Conditions

Old Age

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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:

  • test the feasibility, acceptance and adherence to the supplement and its safety
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multi-nutrient supplement

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Feasibility: recruitment rate

    Time frame: Recruitment over 2 years

    Recruitment rate (measured in %, compared to expected rates)

  2. Feasibility: adherence to intervention

    Time frame: Over 16 weeks

    Adherence to supplements (measured in %, compared to expected rates)

  3. Feasibility: completion

    Time frame: Over 16 weeks

    Completion of study outcome assessments (measured in %, compared to expected rates)

Secondary outcomes

  1. 6-minute walking test

    Time frame: Weeks 0, 8 and 16

    6-minute walking test (measured as the distance walked during 6 minutes, along a 30-m corridor, expressed in m)

  2. Chair stand test

    Time frame: Weeks 0, 8 and 16

    30-second chair stand test: measured as the number of stands from a chair without arms, in 30 sec)

  3. Timed-up-and-go test

    Time frame: Weeks 0, 8 and 16

    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)

  4. Handgrip strength

    Time frame: Weeks 0, 8 and 16

    Maximal handgrip strength (using hand-held Jamar dynamometer, measured in kg),

  5. Leg strength

    Time frame: Weeks 0, 8 and 16

    Isometric knee extension peak torque (using Biodex, measured in N)

  6. Appendicular lean mass

    Time frame: Weeks 0 and 16

    Sum of soft lean mass from arms and legs (measured by iDXA, in kg)

Other outcomes

  1. Protein intake

    Time frame: Weeks 0, 8 and 16

    Protein intake (g) from foods and supplements, estimated from 3-day food diary (using Food Processor with Canadian Nutrient File)

  2. Step counts

    Time frame: Weeks 0, 8 and 16

    Measured by accelerometry during 4 days (Actigraph)

  3. Serum albumin

    Time frame: Weeks 0, 8 and 16

    Albumin, in g/L (measured by the MUHC biochemical laboratory)

  4. Serum pre-albumin

    Time frame: Weeks 0, 8 and 16

    Pre-albumin, in mg/L (measured by the MUHC biochemical laboratory)

  5. Serum C-reactive Protein

    Time frame: Weeks 0, 8 and 16

    CRP, in mg/L (measured by the MUHC biochemical laboratory)

  6. Serum Vitamin D

    Time frame: Weeks 0, 8 and 16

    Vitamin D status, 25(OH)D, in nmol/L (measured by the MUHC biochemical laboratory)

  7. Plasma glucose

    Time frame: Weeks 0, 8 and 16

    Glucose, in mmol/L (measured with glucose oxidase method)

  8. Serum IGF-1

    Time frame: Weeks 0, 8 and 16

    IGF-1, in ng/mL (measured by ELISA)

  9. Plasma phospholipid omega-3 fatty acids

    Time frame: Weeks 0, 8 and 16

    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)

  10. Energy intake

    Time frame: Weeks 0, 8 and 16

    energy intake (kcal) from average of 3-day food diary (using Food Processor with Canadian Nutrient File)

Sponsors and collaborators

Lead sponsor

McGill University

Other

Collaborators

  • MUHC-Montreal General Hospital Foundation
  • Réseau québécois de recherche sur le vieillissement

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Jul 1, 2020
Registry last updated
Jul 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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