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Old AgeNCT04454359

Multi-nutrient Supplement to Improve Physical Performance in Older Adults

A study testing Multi-nutrient supplement in people with Old Age, run by McGill University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Old Age
What is being tested?
Multi-nutrient supplement
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
No sites listed yet
Study dates
10 Aug 2016to 10 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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,
Show all 11Show fewer
  • 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

About this study

Official title: 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.

Read the 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
Being tested
Multi-nutrient supplement, Placebo
Keywords
nutritional supplement, loss of autonomy, rehabilitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-nutrient supplementDietary supplement

  • PlaceboDietary supplement

Study groups in NCT04454359
Study groupRoleWhat they receive
EXPExperimentalEXP 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.
Receives: Dietary Supplement: Multi-nutrient supplement
CTRPlacebo comparatorControl 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.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility: recruitment rate

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

    Measured: Recruitment over 2 years

  2. Feasibility: adherence to intervention

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

    Measured: Over 16 weeks

  3. Feasibility: completion

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

    Measured: Over 16 weeks

Secondary outcomes (6)

  1. 6-minute walking test

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

    Measured: Weeks 0, 8 and 16

  2. Chair stand test

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

    Measured: Weeks 0, 8 and 16

  3. 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)

    Measured: Weeks 0, 8 and 16

  4. Handgrip strength

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

    Measured: Weeks 0, 8 and 16

  5. Leg strength

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

    Measured: Weeks 0, 8 and 16

  6. Appendicular lean mass

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

    Measured: Weeks 0 and 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2020
  2. Study start10 Aug 2016
  3. Primary completion31 Aug 2018
  4. Study completion10 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, placebo-controlled, double-blinded pilot trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04454359
Sponsor's protocol ID
15-633-MUHC
Status last verified
Jun 2020
First submitted
25 Jun 2020
Last updated
1 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD sharing was not planned originally and therefore consent was not obtained for it.

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.

    PubMed 34424934

Questions about this trial

What is this clinical trial studying?

A study testing Multi-nutrient supplement in people with Old Age, run by McGill University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility: recruitment rate (time frame: Recruitment over 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04454359, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2020.

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