Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/10/2012
Date assigned
05/10/2012
Last edited
30/01/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Abbie Cawood

ORCID ID

Contact details

Department of Nutrition and Dietetics
Mail Point 32
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
-
a.l.cawood@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

13116

Study information

Scientific title

A randomised trial of oral nutritional supplements and dietary advice versus dietary advice alone on clinical outcomes in malnourished community dwelling individuals

Acronym

Study hypothesis

This 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

NRES Committee South Central - Southampton A, First MREC approval date: 10/09/2012, ref: 12/SC/0423

Study design

Randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Malnutrition in the elderly

Intervention

1. Dietary Advice: Dietary Advice written information
2. Oral Nutritional Supplements + Dietary Advice

Follow Up Length: 12 month(s)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Quality of Life (QOL) at baseline (BL), wk 4,8,12, 6 months and optional 12 months

Secondary outcome measures

1. 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 trial start date

15/10/2012

Overall trial end date

01/09/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned Sample Size: 300; UK Sample Size: 300

Participant exclusion criteria

1. 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

Recruitment start date

14/12/2012

Recruitment end date

01/09/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southampton General Hospital
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

Southampton University Hospitals NHS Trust (UK)

Sponsor details

Tremona Road
Southampton
SO16 6YD
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Nutricia Ltd (UK) - educational grant

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

Publication citations

Additional files

Editorial Notes