Oral nutritional supplements and dietary advice versus dietary advice alone on clinical outcomes in malnourished community dwelling individuals

ISRCTN ISRCTN26004104
DOI https://doi.org/10.1186/ISRCTN26004104
Secondary identifying numbers 13116
Submission date
03/10/2012
Registration date
05/10/2012
Last edited
20/02/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
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.

Who can participate?
Men and women aged over 50 with disease-related malnutrition.

What does the study involve?
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.

What are the possible benefits and risks of participating?
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.

Where is the study run from?
Southampton General Hospital (UK).

When is the study starting and how long is it expected to run for?
The study started in October 2012 and will finish in October 2015.

Who is funding the study?
Nutricia Ltd (UK).

Who is the main contact?
Dr Abbie Cawood
a.l.cawood@soton.ac.uk

Contact information

Dr Abbie Cawood
Scientific

Department of Nutrition and Dietetics
Mail Point 32
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Email a.l.cawood@soton.ac.uk

Study information

Study designRandomised trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised trial of oral nutritional supplements and dietary advice versus dietary advice alone on clinical outcomes in malnourished community dwelling individuals
Study objectivesThis randomised trial will investigate the efficacy of oral nutritional supplements and dietary advice (information on food fortification, snacks, food choice) as first-line treatments for disease-related malnutrition in non-institutionalised free living older people.

This trial in free living older people, aims to investigate whether oral nutritional supplements and dietary advice as a first line treatment for malnutrition are more clinically and cost effective than giving dietary advice alone.

More details can be found at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=13116

On 31/10/2014 the overall trial end date was changed from 15/10/2015 to 01/09/2016.
Ethics approval(s)NRES Committee South Central - Southampton A, First MREC approval date: 10/09/2012, ref: 12/SC/0423
Health condition(s) or problem(s) studiedMalnutrition in the elderly
Intervention1. Dietary Advice: Dietary Advice written information
2. Oral Nutritional Supplements + Dietary Advice

Follow Up Length: 12 month(s)
Intervention typeOther
Primary outcome measureQuality of Life (QOL) at baseline (BL), wk 4,8,12, 6 months and optional 12 months
Secondary outcome measures1. Acceptability and complicance at BL, weeks 4, 8, 12
2. Clinical / Functional at BL, weeks 4, 8, 12, 6 months and optional 12 months
3. Intake at BL, weeks 4,8,12, 6 months and optional 12 months
4. Resource Use at BL, weeks 4, 8, 12, 6 months, optional 12 months
5. Weight at BL, weeks 4, 8, 12, 6 months and optional 12 months
Overall study start date15/10/2012
Completion date01/09/2016

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participantsPlanned Sample Size: 300; UK Sample Size: 300
Key inclusion criteria1. Male or female
2. Age > 50 years
3. Disease-related malnutrition using Malnutrition Universal Screening Tool (MUST)
4. Malnutrition caused by disease/clinical condition
5. Competent to provide written informed consent and able to answer questions
6. Able to eat and drink
7. Willingness to take part in the trial and to follow the trial protocol
Key exclusion criteria1. Galactosemia or known lactose intolerance
2. Currently receiving (or likely to receive in next 12 weeks) nutritional support including dietary advice, oral nutritional supplements, tube or parenteral nutrition
3. Chronic renal disease requiring dialysis
4. Dysphagia
5. Poorly controlled diabetes
6. Liver failure
7. Cancer
8. Palliative / end of life care
9. Active malignancy / active cancer treatment / palliative care
10. Malnutrition as a result of social factors e.g. unable to purchase food
11. Currently residing in an institution to receive care e.g. care home
12. Participation in other clinical trials
Date of first enrolment14/12/2012
Date of final enrolment01/09/2015

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Southampton General Hospital
Southampton
SO16 6YD
United Kingdom

Sponsor information

Southampton University Hospitals NHS Trust (UK)
University/education

Tremona Road
Southampton
SO16 6YD
England
United Kingdom

ROR logo "ROR" https://ror.org/0485axj58

Funders

Funder type

Industry

Nutricia Ltd (UK) - educational grant

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Abstract results results presented at ESPEN : 01/09/2017 No No
Abstract results results presented at ESPEN : 01/09/2017 No No
Abstract results results presented at ESPEN : 01/04/2018 No No
Abstract results results presented at ESPEN : 01/09/2018 No No

Editorial Notes

20/02/2019: Publication references added