Contact information
Type
Scientific
Primary contact
Dr Elizabeth Williams
ORCID ID
Contact details
Human Nutrition Unit
School of Medicine and Biomedical Sciences
The University of Sheffield
Beech Hill Road
Sheffield
S10 2JX
United Kingdom
+44 (0)114 271 1567
e.a.williams@sheffield.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N05068
Study information
Scientific title
Acronym
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
This study looks at immune function in healthy subjects
Intervention
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
Other
Phase
Not Specified
Drug names
Primary outcome measures
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
01/04/2006
Overall trial end date
31/03/2009
Reason abandoned
Eligibility
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
Senior
Gender
Both
Target number of participants
216
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
01/04/2006
Recruitment end date
31/03/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Human Nutrition Unit
Sheffield
S10 2JX
United Kingdom
Sponsor information
Organisation
The University of Sheffield (UK)
Sponsor details
Research Office
Research Services
New Spring House
231 Glossop Road
Sheffield
S10 2GW
United Kingdom
+44 (0)114 222 1469
research.office@sheffield.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Food Standards Agency (UK) (ref: N05068)
Alternative name(s)
FSA
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
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
Results - basic reporting
Publication summary
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20175903
Publication citations
-
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.