Effect of a dietary intervention on Functional Immune sTatus in the elderly

ISRCTN	ISRCTN45031464
DOI	https://doi.org/10.1186/ISRCTN45031464
Protocol serial number	N05068
Sponsor	The University of Sheffield (UK)
Funder	Food Standards Agency (UK) (ref: N05068)

Submission date: 24/05/2007
Registration date: 13/08/2007
Last edited: 05/11/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Elizabeth Williams
Scientific

Human Nutrition Unit
School of Medicine and Biomedical Sciences
The University of Sheffield
Beech Hill Road
Sheffield
S10 2JX
United Kingdom

Phone	+44 (0)114 271 1567
Email	e.a.williams@sheffield.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised, controlled, single centre trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	The FIT study
Study objectives	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(s)	Approval received from the Barnsley Research Ethics Committee on the 10th October 2005 (ref: 05/Q2304/48).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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.
Completion date	31/03/2009

Eligibility

Participant type(s)	Healthy volunteer
Age group	Senior
Sex	All
Target sample size at registration	216
Key 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)
Key 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
Date of first enrolment	01/04/2006
Date of final enrolment	31/03/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Human Nutrition Unit

Sheffield
S10 2JX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	22/02/2010		Yes	No