Old Age
Conditions
Keywords
nutritional supplement, loss of autonomy, rehabilitation
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.
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.
Interventions
DIETARY_SUPPLEMENTMulti-nutrient supplement
DIETARY_SUPPLEMENTPlacebo
Sponsors
Réseau québécois de recherche sur le vieillissement
MUHC-Montreal General Hospital Foundation
McGill University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Isocaloric placebos of same taste and texture as the experimental supplements
Intervention model description
Randomized, placebo-controlled, double-blinded pilot trial
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: recruitment rate | Recruitment over 2 years | Recruitment rate (measured in %, compared to expected rates) |
| Feasibility: adherence to intervention | Over 16 weeks | Adherence to supplements (measured in %, compared to expected rates) |
| Feasibility: completion | Over 16 weeks | Completion of study outcome assessments (measured in %, compared to expected rates) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Handgrip strength | Weeks 0, 8 and 16 | Maximal handgrip strength (using hand-held Jamar dynamometer, measured in kg), |
| 6-minute walking test | 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) |
| Appendicular lean mass | Weeks 0 and 16 | Sum of soft lean mass from arms and legs (measured by iDXA, in kg) |
| Leg strength | Weeks 0, 8 and 16 | Isometric knee extension peak torque (using Biodex, measured in N) |
| Chair stand test | Weeks 0, 8 and 16 | 30-second chair stand test: measured as the number of stands from a chair without arms, in 30 sec) |
| Timed-up-and-go test | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Protein intake | 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) |
| Energy intake | Weeks 0, 8 and 16 | energy intake (kcal) from average of 3-day food diary (using Food Processor with Canadian Nutrient File) |
| Step counts | Weeks 0, 8 and 16 | Measured by accelerometry during 4 days (Actigraph) |
| Serum albumin | Weeks 0, 8 and 16 | Albumin, in g/L (measured by the MUHC biochemical laboratory) |
| Serum pre-albumin | Weeks 0, 8 and 16 | Pre-albumin, in mg/L (measured by the MUHC biochemical laboratory) |
| Serum C-reactive Protein | Weeks 0, 8 and 16 | CRP, in mg/L (measured by the MUHC biochemical laboratory) |
| Serum Vitamin D | Weeks 0, 8 and 16 | Vitamin D status, 25(OH)D, in nmol/L (measured by the MUHC biochemical laboratory) |
| Plasma glucose | Weeks 0, 8 and 16 | Glucose, in mmol/L (measured with glucose oxidase method) |
| Serum IGF-1 | Weeks 0, 8 and 16 | IGF-1, in ng/mL (measured by ELISA) |
| Plasma phospholipid omega-3 fatty acids | 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) |
Outcome results
None listed