The FOOD Trials - Feed Or Ordinary Diet in stroke (2005)

The FOOD trial was a family of three multicentre trials to evaluate feeding policies in patients with a recent stroke.

A total of 5033 patients who had been admitted to hospital with a recent stroke were enrolled in the trials at 131 hospitals in 18 countries. The findings did not support routine supplementation of the hospital diet; that early tube feeding may substantially reduce the risk of dying after stroke; and that better functional outcomes resulted from feeding via NG tube than PEG tube.

Trial dates

1996-2005

Trial team

Principal Investigator: Prof Martin Dennis

Trial Co-ordinator: Gina Cranswick

Trial Statistician: Dave Signorini

Trial Programmer: Vera Soosay

Scientific advisory group: Campbell Chalmers, Martin Dennis (Chair), John Forbes, Subrata Ghosh, Peter Langhorne, Carole Ann McAteer, Jean McIntyre, Paul O’Neill, Jan Potter and Margaret Roberts.

Administrative, data management and trial development group: Gina Cranswick, Martin Dennis, Barbara Farrell, Anne Leigh Brown, Dave Signorini, Vera Soosay and Charles Warlow (Chair).

Data Monitoring Committee: Professor C Bulpitt (London), Professor A Grant (Aberdeen, Chair), Professor G Murray (Edinburgh) and Dr P Sandercock (Edinburgh).

Summary & findings

FOOD was a family of three trials. Functional outcome was measured using the modified Rankin scale (MRS) after 6 months.

Trial 1

In patients with a recent stroke, who can take adequate fluids orally, does oral nutritional supplementation increase the proportion of patients surviving without disability?

• Patients who could swallow within the first 30 days of admission were allocated to normal hospital diet versus normal hospital diet plus oral nutritional supplements (equivalent to 360 ml of 1.5 kcal/ml, 20 g of protein per day) until hospital discharge. 4023 patients were enrolled by 125 hospitals in 15 countries.
• The results did not support routine supplementation of hospital diet for unselected stroke patients who are predominantly well nourished on admission.

Trial 2

In patients with a recent stroke, who are unable to take adequate fluids orally, does early initiation of tube feeding (NG or PEG) increase the proportion of patients surviving without  severe disability?

• Dysphagic patients enrolled within 7 days of admission were allocated to early enteral tube feeding versus avoid any enteral tube feeding for at least 1 week. 859 patients were enrolled by 83 hospitals in 15 countries.
• In Trial 2, the data suggested that a policy of early tube feeding may substantially reduce the risk of dying after stroke and it is very unlikely that the alternative policy of avoiding early tube feeding would significantly improve survival.

Trial 3

In patients with a recent stroke who need tube feeding, is a PEG tube, instead of traditional NG tube, associated with better outcomes?

• Dysphagic patients were allocated within 30 days of admission to receive enteral tube feeding via PEG versus NG. 321 patients were enrolled by 47 hospitals in 11 countries
• The data from trial 3 suggested that in the first 2-3 weeks after acute stroke, better functional outcomes result from feeding via NG tube than PEG tube, although there was no major difference in survival. These data did not support a policy of early initiation of PEG feeding in dysphagic stroke patients.  

FOOD trial full protocol (130.09 KB PDF)

Publications

1: Dennis MS, Lewis S, Cranswick GM. Senior physicians' estimates of the likely effects of feeding policies on outcomes prior to the completion of the FOOD trials. Age Ageing. 2006 Mar;35(2):185-7. doi: 10.1093/ageing/afj028. Epub 2006 Jan 18.

2: Dennis M, Lewis S, Cranswick G, Forbes J; FOOD Trial Collaboration. FOOD: a multicentre randomised trial evaluating feeding policies in patients admitted to hospital with a recent stroke. Health Technol Assess. 2006 Jan;10(2):iii-iv, ix-x, 1-120. doi: 10.3310/hta10020.

3: Dennis MS, Lewis SC, Warlow C; FOOD Trial Collaboration. Effect of timing and method of enteral tube feeding for dysphagic stroke patients (FOOD): a multicentre randomised controlled trial. Lancet. 2005 Feb 26-Mar 4;365(9461):764-72. doi: 10.1016/S0140-6736(05)17983-5.

4: Dennis MS, Lewis SC, Warlow C; FOOD Trial Collaboration. Routine oral nutritional supplementation for stroke patients in hospital (FOOD): a multicentre randomised controlled trial. Lancet. 2005 Feb 26-Mar 4;365(9461):755-63. doi: 10.1016/S0140-6736(05)17982-3.

Funding

The trial received the bulk of its funding from the HS R&D Health Technology Assessment (HTA) Board. However, the start-up phase was supported by grants from the Stroke Association, Chief Scientist Office of the Scottish Executive and Chest, Heart and Stroke Scotland. In addition, the Stroke Association awarded a second grant to support the centres participating in the main phase of the trial.