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| Name | Class |
|---|---|
| Réseau québécois de recherche sur le vieillissement | UNKNOWN |
| MUHC-Montreal General Hospital Foundation | UNKNOWN |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-nutrient supplement | Dietary Supplement |
| ||
| Placebo |
| 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 |
| 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) |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stéphanie Chevalier, PhD | Research Institute of the McGill University Health Centre | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34424934 | Derived | 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. |
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IPD sharing was not planned originally and therefore consent was not obtained for it.
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Randomized, placebo-controlled, double-blinded pilot trial
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Isocaloric placebos of same taste and texture as the experimental supplements
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| 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 |
| 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 |