Multi-nutrient Supplement to Improve Physical Performance in Older Adults

Old Age Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04454359
• Other study ID #: 15-633-MUHC
• Status: Completed
• Phase: N/A
• Start date: August 10, 2016
• Est. completion date: March 10, 2020

Study information

• Verified date: June 2020
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 10, 2020
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Old Age

Intervention

Dietary Supplement:
• Multi-nutrient supplement

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
McGill University	MUHC-Montreal General Hospital Foundation, Réseau québécois de recherche sur le vieillissement

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Step counts	Measured by accelerometry during 4 days (Actigraph)	Weeks 0, 8 and 16
Other	Serum albumin	Albumin, in g/L (measured by the MUHC biochemical laboratory)	Weeks 0, 8 and 16
Other	Serum pre-albumin	Pre-albumin, in mg/L (measured by the MUHC biochemical laboratory)	Weeks 0, 8 and 16
Other	Serum C-reactive Protein	CRP, in mg/L (measured by the MUHC biochemical laboratory)	Weeks 0, 8 and 16
Other	Serum Vitamin D	Vitamin D status, 25(OH)D, in nmol/L (measured by the MUHC biochemical laboratory)	Weeks 0, 8 and 16
Other	Plasma glucose	Glucose, in mmol/L (measured with glucose oxidase method)	Weeks 0, 8 and 16
Other	Serum IGF-1	IGF-1, in ng/mL (measured by ELISA)	Weeks 0, 8 and 16
Other	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
Other	Energy intake	energy intake (kcal) from average of 3-day food diary (using Food Processor with Canadian Nutrient File)	Weeks 0, 8 and 16
Primary	Feasibility: recruitment rate	Recruitment rate (measured in %, compared to expected rates)	Recruitment over 2 years
Primary	Feasibility: adherence to intervention	Adherence to supplements (measured in %, compared to expected rates)	Over 16 weeks
Primary	Feasibility: completion	Completion of study outcome assessments (measured in %, compared to expected rates)	Over 16 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Handgrip strength	Maximal handgrip strength (using hand-held Jamar dynamometer, measured in kg),	Weeks 0, 8 and 16
Secondary	Leg strength	Isometric knee extension peak torque (using Biodex, measured in N)	Weeks 0, 8 and 16
Secondary	Appendicular lean mass	Sum of soft lean mass from arms and legs (measured by iDXA, in kg)	Weeks 0 and 16