Effect of a dietary intervention on Functional Immune sTatus in the elderly
| ISRCTN | ISRCTN45031464 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45031464 |
| Secondary identifying numbers | 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
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 |
|---|---|
| e.a.williams@sheffield.ac.uk |
Study information
| Study design | Randomised, controlled, single centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| 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 | 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 study start date | 01/04/2006 |
| Completion date | 31/03/2009 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Human Nutrition Unit
Sheffield
S10 2JX
United Kingdom
S10 2JX
United Kingdom
Sponsor information
The University of Sheffield (UK)
University/education
University/education
Research Office
Research Services
New Spring House
231 Glossop Road
Sheffield
S10 2GW
England
United Kingdom
| Phone | +44 (0)114 222 1469 |
|---|---|
| research.office@sheffield.ac.uk | |
| Website | http://www.shef.ac.uk |
"ROR" |
https://ror.org/05krs5044 |
Funders
Funder type
Government
Food Standards Agency (UK) (ref: N05068)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- The Food Standards Agency, FSA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
