Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2002
Date assigned
12/09/2002
Last edited
08/06/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr SE Gariballa

ORCID ID

Contact details

Sheffield Institute for Studies on Ageing
Community Sciences Centre
Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom
+44 (0)114 271 5124
s.e.gariballa@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

577/484

Study information

Scientific title

Acronym

FED Trial

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised double-blind placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Nutritional status in the elderly

Intervention

Elderly patients referred for an active period of rehabilitation following an episode of acute illness are randomised to:
1. Normal hospital diet plus placebo, or
2. Normal hospital diet plus oral supplements for 6 weeks

Normal diet is what is normally provided to patients. All patients will have nutritional supplements or placebo prescribed in their drug charts. The supplement group will receive a daily oral nutritional supplement 400 ml or more given daily at 15.00 and 20.00 hours in addition to the standard hospital diet. The composition of the supplement is such as to provide between 100 - 150% of the Reference Nutrient Intakes for a healthy old person for the following nutrients: carbohydrates, protein, fat, vitamins (A, C, D, E, B1, B2, B6, B12, folic acid, niacin, biotin and pantothenic acid), and minerals (potassium, magnesium, calcium, phosphorous, chloride, iron, zinc, iodine, copper, manganese and selenium).

Supplementation will continue for a period of 6 weeks. This will be either entirely in hospital or in the community also for patients discharged earlier than 6 weeks. For those discharged earlier than 6 weeks supplies will be given for patients to take in the community and they or their carers will be shown how to fill in food diary cards for the remaining period. The placebo will be identical to the supplement but will contain no protein or micronutrients and with a minimum calorie content in it to make it tasty and palatable to patients. Different flavours of supplements and placebo will be prepared and tested initially in a pilot study and those most liked by patients will be made available for patients to choose from.

Intervention type

Supplement

Phase

Not Specified

Drug names

Nutritional supplements

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2000

Overall trial end date

01/01/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients will be eligible for the study if they meet the following criteria:
1. Age 65 years, stable medical condition, referred for an active rehabilitation program
2. Able to swallow
3. Able to sign an informed written consent form

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

445

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2000

Recruitment end date

01/01/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Sheffield Institute for Studies on Ageing
Sheffield
S5 7AU
United Kingdom

Sponsor information

Organisation

The Health Foundation (UK)

Sponsor details

90 Long Acre
London
WC2E 9RA
United Kingdom
+44 (0)20 7257 8000
info@health.org.uk

Sponsor type

Charity

Website

http://www.pppfoundation.org.uk/

Funders

Funder type

Charity

Funder name

The Health Foundation (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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16815489

Publication citations

  1. Results

    Gariballa S, Forster S, Effects of acute-phase response on nutritional status and clinical outcome of hospitalized patients., Nutrition, 22, 7-8, 750-757, doi: 10.1016/j.nut.2006.04.011.

Additional files

Editorial Notes