Does the oral nutritional supplementation of undernourished older people after hospital discharge improve muscle function? A two centre double blind placebo controlled trial
| ISRCTN | ISRCTN33287248 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33287248 |
| Secondary identifying numbers | CZH/4/283 |
- Submission date
- 07/07/2005
- Registration date
- 21/10/2005
- Last edited
- 23/05/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Maintaining muscle strength in old age is very important since it is linked with walking and balance. Poor nutrition is associated with loss of muscle and reduced muscle function. It is known that providing extra nourishment can benefit undernourished older people while they are in hospital, but at present it is not known whether supplementing the diet after discharge from hospital would be also beneficial. The aim of this study is to find out whether giving extra nourishment improves muscle function in older people.
Who can participate?
Undernourished older people (age 70 and over) returning home after being in hospital with an acute illness
What does the study involve?
The study dietician takes some standard body measurements including weight and height. Participants are randomly allocated receive either two cartons (200ml each) per day of a milk-based supplement or to a similar drink which has minimal nutrients (placebo). A supply of these drinks is given free of charge one week after discharge from hospital and replenished by the study dietician at each visit. Handgrip and leg strength are measured twice while participants are in hospital. Assessing leg strength involves recording how long it takes to complete 10 full stands from a sitting position. On their day of discharge participants are given an accelerometer (a device the size of a matchbox worn on the waistband which measures how active they are) which they are asked to wear during waking hours for the next 7 days. This is collected by the dietician at the end of 7 days. The study dietician visits participants in their homes on three separate occasions over a 16-week period. On each occasion weight, handgrip and leg strength are measured. Two brief questionnaires are completed which look at basic activities associated with daily living and quality of life. A list of all food eaten in the 72 hours before the visit needs to be written down in the food diary provided. Each visit is likely to last for no more than 40 minutes.
What are the possible benefits and risks of participating?
Participants receiving the nutritional supplements receive extra nourishment that would not normally be part of usual care. Taking part in this study involves assessing muscle function and recording body weight which means that participants need to be able to stand unsupported. These procedures are very straightforward to do, may involve a little exertion but are painless and do not involve any risk.
Where is the study run from?
Ninewells Hospital & Medical School (UK)
When is the study starting and how long is it expected to run for?
February 2006 to July 2008
Who is funding the study?
Chief Scientist Office (UK)
Who is the main contact?
Prof. Marion McMurdo
Contact information
Scientific
Ageing and Health
Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Does the oral nutritional supplementation of undernourished older people after hospital discharge improve muscle function? A two centre double blind placebo controlled trial |
| Study objectives | Added 23/05/2018: Oral nutritional supplementation is associated with a reduction in disability in undernourished older people after hospital discharge |
| Ethics approval(s) | Tayside Committee on Medical Research Ethics, 18/02/2005, ref: 05/S1401/05 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/02/2006 |
| Completion date | 30/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 320 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2006 |
| Date of final enrolment | 30/07/2008 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
DD1 9SY
United Kingdom
Sponsor information
University/education
Research & Innovation Services
University of Dundee
Dundee
DD1 9SY
Scotland
United Kingdom
"ROR" |
https://ror.org/03h2bxq36 |
|---|
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- CSO
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | The protocol is available from the authors on request but is not available online. Study data are available for non-commercial, bona-fide academic analyses in collaboration with the authors; decisions on data access will be made between the investigators and the Sponsor (University of Dundee). Participant consent for unrestricted sharing of individual participant data was not obtained. Contact for data sharing: Dr Catrina Forde (c.forde@dundee.ac.uk) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2009 | Yes | No | |
| Basic results | 23/05/2018 | 23/05/2018 | No | No |
Additional files
- ISRCTN33287248_BasicResults_23May18.pdf
- Uploaded 23/05/2018
Editorial Notes
23/05/2018: IPD sharing statement, hypothesis, ethics approval, plain English summary added. The basic results of this trial have been uploaded as an additional file.
