Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CZH/4/283
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Undernourished older people admitted with an acute illness
Intervention
Complete liquid protein and energy supplement (400 ml/day) or matching liquid placebo with minimal protein and energy content over a 12 week period.
Intervention type
Supplement
Phase
Not Specified
Drug names
Nutritional supplementation
Primary outcome measures
1. Changes in muscle strength (handgrip dynamometry)
2. Changes in disability (Barthel index)
Secondary outcome measures
1. Changes in lower limb muscle strength
2. Changes in weight
3. Changes in dietary intake (24 hour dietary recall)
4. Changes in daily physical activity levels (accelerometry)
5. Changes in health related quality of life (Euroquol)
6. Unplanned hospital readmissions
Overall trial start date
01/02/2006
Overall trial end date
30/07/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age 70 years and over
2. Community dwelling
3. Admitted to hospital with an acute illness
4. Body mass index ≤24 kg/m^2
5. Mid-arm muscle circumference below the 10th centile and/or weight loss of 5% or more during hospital stay
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
320
Participant exclusion criteria
1. Chronic liver diease or renal failure
2. Nursing home residents
3. Cognitive impairment precluding informed consent
4. Dysphagia
5. Metastatic carcinoma or other terminal illness
6. Pathology such as inflammatory arthritis or stroke affecting non-dominant handgrip
7. Major surgery within one month
Recruitment start date
01/02/2006
Recruitment end date
30/07/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Ageing and Health
Dundee
DD1 9SY
United Kingdom
Funders
Funder type
Government
Funder name
Chief Scientist Office, Scottish Executive (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19925613
Publication citations
-
Results
McMurdo ME, Price RJ, Shields M, Potter J, Stott DJ, Should oral nutritional supplementation be given to undernourished older people upon hospital discharge? A controlled trial., J Am Geriatr Soc, 2009, 57, 12, 2239-2245, doi: 10.1111/j.1532-5415.2009.02568.x.