Multi-nutrient Supplement to Improve Physical Performance in Older Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Old Age

Intervention / Treatment
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* Dietary Supplement: Multi-nutrient supplement
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, placebo-controlled, double-blinded pilot trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EXP<br>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<br> <br> |
| Placebo Comparator: CTR<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutritional supplement, loss of autonomy, rehabilitation