Multi-nutrient Supplement to Improve Physical Performance in Older Adults

NCT04454359 | Completed

• 1 other identifier: 15-633-MUHC
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Old Age

Keywords

nutritional supplement; loss of autonomy; rehabilitation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 6-minute walking test

  Weeks 0, 8 and 16

• Chair stand test

  Weeks 0, 8 and 16

• Timed-up-and-go test

  Weeks 0, 8 and 16

• Handgrip strength

  Weeks 0, 8 and 16

• Leg strength

  Weeks 0, 8 and 16

Other Outcomes (10)

• Protein intake

  Weeks 0, 8 and 16

• Step counts

  Weeks 0, 8 and 16

• Serum albumin

  Weeks 0, 8 and 16

Study Arms (2)

EXP

EXPERIMENTAL

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

CTR

PLACEBO COMPARATOR

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

Interventions

Multi-nutrient supplement DIETARY_SUPPLEMENT

EXP

Placebo DIETARY_SUPPLEMENT

CTR

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University: lead
• Réseau québécois de recherche sur le vieillissement: collaborator
• MUHC-Montreal General Hospital Foundation: collaborator

Related Publications (1)

• 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.

  PMID: 34424934 DERIVED

Study Officials

• Stéphanie Chevalier, PhD

  Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Isocaloric placebos of same taste and texture as the experimental supplements
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized, placebo-controlled, double-blinded pilot trial

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: July 1, 2020
• Study Start: August 10, 2016
• Primary Completion: August 31, 2018
• Study Completion: March 10, 2020
• Last Updated: July 1, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share