Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Elizabeth Williams


Contact details

Human Nutrition Unit
School of Medicine and Biomedical Sciences
The University of Sheffield
Beech Hill Road
S10 2JX
United Kingdom
+44 (0)114 271 1567

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


The FIT study

Study hypothesis

We hypothesise that:
1. There is a relationship between nutritional status, dietary intake and immune function in the elderly
2. Improving nutritional status will enhance immune function in the elderly

Ethics approval

Approval received from the Barnsley Research Ethics Committee on the 10th October 2005 (ref: 05/Q2304/48).

Study design

Randomised, controlled, single centre trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type

Quality of life

Patient information sheet


This study looks at immune function in healthy subjects


Volunteers will be randomised to one of three intervention groups:
1. Dietary intervention: volunteers will be asked to consume a diet aimed at increasing the intake of fruit and vegetables (to five portions/day), fish (to two portions/week), and to increase consumption of wholemeal bread and nuts
2. Micronutrient supplement: vitamin C, beta carotene, zinc, selenium, vitamin E
3. Placebo

Each intervention will be for three months. Volunteers will be followed up for three months post-intervention.

Intervention type



Not Specified

Drug names

Primary outcome measure

1. Innate and adaptive immunity, measured using:
1.1. High-Sensitivity C-Reactive Protein (hSCRP)
1.2. Natural killer cell cytotoxicity
1.3. Neutrophil and monocyte oxidative burst and phagocytic activity
1.4. T-cell activation
1.5. Reponse to tetanus vaccine (administered at eight weeks)
2. Nutritional status, measured by:
2.1. Plasma carotenoids
2.2. Retinol
2.3. Vitamin E
2.4. Ascorbic acid
2.5. Selenium
2.6. Glutathione peroxidase
2.7. Zinc
3. Number of days infection, measured using a self-reported infection diary

The primary and secondary outcomes will be measured at baseline, end of intervention and three months post-intervention, with the exception of the response to tetanus vaccine which is measured at 8 weeks and 12 weeks only (coinciding with tetanus vaccination and end of intervention).

Secondary outcome measures

1. Dietary intake and dietary change, measured using three-day food diaries
2. Physical activity, measured with the Community Healthy Activities Model Program for Seniors (CHAMPS) physical activity questionnaire
3. Quality of life, measured using the 36-item Geriatric Depression Scale (GDS36)
4. Body composition, measured by body weight, height, triceps skin-fold thickness

The primary and secondary outcomes will be measured at baseline, end of intervention and three months post-intervention.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Men and women
2. Community based healthy volunteers
3. Aged 65 to 85 years
4. Living an active independent life
5. Low intake of fruit and vegetables (less than or equal to two portions per day)

Participant type

Healthy volunteer

Age group




Target number of participants


Participant exclusion criteria

1. Hospitalised within past 12 months
2. Current or recent (within three months) users of micronutrient supplements
3. Have a Body Mass Index (BMI) less than 18 or more than 30
4. Have a special diet or about to embark on a weight loss diet
5. Have a malignancy or severe medical or psychiatric illness
6. Cannot understand or communicate effectively
7. Have insulin-dependent diabetes mellitus

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Human Nutrition Unit
S10 2JX
United Kingdom

Sponsor information


The University of Sheffield (UK)

Sponsor details

Research Office
Research Services
New Spring House
231 Glossop Road
S10 2GW
United Kingdom
+44 (0)114 222 1469

Sponsor type




Funder type


Funder name

Food Standards Agency (UK) (ref: N05068)

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


United Kingdom

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

Basic results (scientific)

Publication list

2010 results in

Publication citations

  1. Results

    Forster SE, Jones L, Saxton JM, Flower DJ, Foulds G, Powers HJ, Parker SG, Pockley AG, Williams EA, Recruiting older people to a randomised controlled dietary intervention trial--how hard can it be?, BMC Med Res Methodol, 2010, 10, 17, doi: 10.1186/1471-2288-10-17.

Additional files

Editorial Notes