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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Abbie Cawood
-
a.l.cawood@soton.ac.uk


Study Location:

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Be Part of Research - Trial Details - Oral nutritional supplements and dietary advice versus dietary advice alone on clinical outcomes in malnourished community dwelling individuals
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Oral nutritional supplements and dietary advice versus dietary advice alone on clinical outcomes in malnourished community dwelling individuals

Not Recruiting

Open to: All Genders

Age: Senior

Southampton

Medical Conditions

Malnutrition in the elderly

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Sometimes the effect of disease means people become malnourished (under-nutrition) and this affects 5% of the UK population, with the majority of people affected living in the community. Malnutrition has adverse consequences including poorer clinical outcomes. Effective management can improve nutritional status and outcomes. UK guidelines recommend that individuals are screened to detect malnutrition and where risk is identified, action is taken to tackle this. Commonly used nutrition strategies for malnourished people who can eat and drink include dietary advice (modifications to the diet to increase nutrient intake) and oral nutritional supplements (nutrient-enriched drinks). There is a lack of evidence to support oral nutrition support strategies for people living in their own homes in the community. The aim of this study is to determine which of these two methods (dietary advice, or advice with oral nutritional supplements) is most effective in individuals identified as being at risk of malnutrition in the community.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

14 Dec 2012 01 Sep 2015

Publications

2017 Abstract results in https://doi.org/10.1016/S0261-5614(17)30769-0 results presented at ESPEN :2017 Abstract results in https://doi.org/10.1016/S0261-5614(17)30635-0 results presented at ESPEN :2018 Abstract results in https://doi.org/10.1016/j.clnu.2017.02.008 results presented at ESPEN :2018 Abstract results in https://doi.org/10.1016/j.clnu.2018.06.1366 results presented at ESPEN :

After giving consent to take part in the study, the participants will be randomly allocated to a nutritional treatment. They will receive either nutritional drinks and a simple diet information leaflet or just receive the simple diet information leaflet for a period of 3 months. After this the treatment will then stop but they will be followed up by the researchers for a further 3 months. They will be involved in the research for a total of 6 months (with an optional follow-up at 12 months). Each participant will see the researcher five times over the 6-month period, with additional phone contact between visits. Each visit will last about 30 minutes. The researcher will visit them in their own home.


Men and women aged over 50 with disease-related malnutrition.

You can take part if:



You may not be able to take part if:


1. Galactosemia or known lactose intolerance2. Currently receiving (or likely to receive in next 12 weeks) nutritional support including dietary advice, oral nutritional supplements, tube or parenteral nutrition3. Chronic renal disease requiring dialysis4. Dysphagia5. Poorly controlled diabetes6. Liver failure7. Cancer8. Palliative / end of life care9. Active malignancy / active cancer treatment / palliative care10. Malnutrition as a result of social factors e.g. unable to purchase food11. Currently residing in an institution to receive care e.g. care home12. Participation in other clinical trials


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Southampton General Hospital
    Southampton
    SO16 6YD

The nutritional treatments used in this study may help to improve the participants' nutritional status and help them to feel better. The study will help health professionals decide the best type of nutritional treatment to use in people with malnutrition living in the community in the future. The treatments used are nutritional treatments (not medicines) that are already widely used in clinical practice for people with poor nutrition and are very unlikely to cause side effects. These treatments are not associated with any risk or disadvantage to health.

Dr Abbie Cawood
-
a.l.cawood@soton.ac.uk



The study is sponsored by Southampton University Hospitals NHS Trust (UK) and funded by Nutricia Ltd (UK) - educational grant.



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Read full details for Trial ID: ISRCTN26004104
Last updated 20 February 2019

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