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ISRCTN
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ISRCTN33287248
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ClinicalTrials.gov identifier
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Public title
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Does the oral nutritional supplementation of undernourished older people after hospital discharge improve muscle function? A two centre double blind placebo controlled trial.
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Scientific title
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Acronym
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N/A
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Serial number at source
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CZH/4/283
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Study hypothesis
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Not provided at time of registration
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Undernourished older people admitted with an acute illness
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/02/2006
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Anticipated end date
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30/07/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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320
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Interventions
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Complete liquid protein and energy supplement (400 ml/day) or matching liquid placebo with minimal protein and energy content over a 12 week period.
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Primary outcome measure(s)
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1. Changes in muscle strength (handgrip dynamometry)
2. Changes in disability (Barthel index)
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Secondary outcome measure(s)
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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
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Sources of funding
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Chief Scientist Office, Scottish Executive (UK)
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Trial website
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19925613
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Contact name
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Prof
Marion
McMurdo
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Address
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Ageing and Health
Ninewells Hospital & Medical School
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City/town
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Dundee
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Zip/Postcode
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DD1 9SY
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Country
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United Kingdom
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Sponsor
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University of Dundee (UK)
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Address
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Research & Innovation Services
University of Dundee
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City/town
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Dundee
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Zip/Postcode
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DD1 9SY
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Country
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United Kingdom
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Date applied
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07/07/2005
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Last edited
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04/03/2010
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Date ISRCTN assigned
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21/10/2005
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