Condition category
Circulatory System
Date applied
20/03/2002
Date assigned
20/03/2002
Last edited
09/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.dcn.ed.ac.uk/food/

Contact information

Type

Scientific

Primary contact

Dr MS Dennis

ORCID ID

Contact details

FOOD Trial Co-ordinating Centre
Neurosciences Trials Unit
Western General Hospital
Edinburgh
EH4 2XU
United Kingdom
+44 (0)131 5372939
MSD@skull.dcn.ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 96/29/01

Study information

Scientific title

Acronym

FOOD

Study hypothesis

FOOD is an international, randomised trial involving a total of at least 4,000 patients which aims to address the following issues:
1. In stroke patients who cannot swallow, does feeding via a Percutaneous Endoscopic Gastrostomy (PEG) tube improve survival free of severe disability compared with that via a nasal gastric (NG) tube? (500 patients in each arm)
2. In patients who cannot swallow within the first week of admission, is immediate initiation of feeding via either a PEG or NG tube (rather than simply hydrating the patient to see if dysphagia will rapidly resolve) associated with improved outcomes? (500 patients in each arm)

We will assess the impact of particular feeding regimes on lower complication rates, mortality, improved quality of life amongst survivors and resource use. Using the same trial infrastructure we will also address a third related question: in patients who can swallow, does routine addition of oral nutritional supplements to the normal hospital diet improve patients' outcomes? (1000 patients in each arm). No additional resources are requested to address this third question. We believe that the inclusion of a trial addressing this last question will facilitate the more rapid completion of the tube feeding arms.

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/962901

On 16/01/2008 the start and end date of this trial were changed from 1/11/1996 and 31/07/2003 to 01/02/1999 and 31/12/2004, respectively.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Stroke

Intervention

Interventions:
Trial 1: Normal hospital diet versus normal hospital diet plus oral supplements (comprising 120 ml containing 1.5 kcal/ml three times a day)
Trial 2: Immediate tube feeding (NG or PEG) versus delay tube feeding for at least a week and hydrate using parenteral fluids
Trial 3: NG versus PEG

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Survival without disability, mortality

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/1999

Overall trial end date

31/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Any patient admitted to hospital with a stroke (excluding those with subarachnoid haemorrhage) within a week of onset, in whom the randomising clinician is substantially uncertain about the best feeding policy

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

4,023

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/02/1999

Recruitment end date

31/12/2004

Locations

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, Hong Kong, India, Ireland, Italy, New Zealand, Poland, Portugal, Singapore, Turkey, United Kingdom

Trial participating centre

FOOD Trial Co-ordinating Centre
Edinburgh
EH4 2XU
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

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

2005 results in: http://www.ncbi.nlm.nih.gov/pubmed/15733716
2005 results in: http://www.ncbi.nlm.nih.gov/pubmed/15733717
2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/16409880

Publication citations

  1. Results

    Dennis MS, Lewis SC, Warlow C, , Routine oral nutritional supplementation for stroke patients in hospital (FOOD): a multicentre randomised controlled trial., Lancet, 365, 9461, 755-763, doi: 10.1016/S0140-6736(05)17982-3.

  2. Results

    Dennis MS, Lewis SC, Warlow C, , Effect of timing and method of enteral tube feeding for dysphagic stroke patients (FOOD): a multicentre randomised controlled trial., Lancet, 365, 9461, 764-772, doi: 10.1016/S0140-6736(05)17983-5.

  3. Results

    Dennis M, Lewis S, Cranswick G, Forbes J, , FOOD: a multicentre randomised trial evaluating feeding policies in patients admitted to hospital with a recent stroke., Health Technol Assess, 2006, 10, 2, iii-iv, ix-x, 1-120.

Additional files

Editorial Notes