Effect of a dietary intervention on Functional Immune sTatus in the elderly
- Conditions
- This study looks at immune function in healthy subjectsNutritional, Metabolic, EndocrineImmune function and nutrition
- Registration Number
- ISRCTN45031464
- Lead Sponsor
- The University of Sheffield (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 216
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Innate and adaptive immunity, measured using:<br>1.1. High-Sensitivity C-Reactive Protein (hSCRP)<br>1.2. Natural killer cell cytotoxicity<br>1.3. Neutrophil and monocyte oxidative burst and phagocytic activity<br>1.4. T-cell activation<br>1.5. Reponse to tetanus vaccine (administered at eight weeks)<br>2. Nutritional status, measured by:<br>2.1. Plasma carotenoids<br>2.2. Retinol<br>2.3. Vitamin E<br>2.4. Ascorbic acid<br>2.5. Selenium<br>2.6. Glutathione peroxidase<br>2.7. Zinc<br>3. Number of days infection, measured using a self-reported infection diary<br><br>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
Name Time Method 1. Dietary intake and dietary change, measured using three-day food diaries<br>2. Physical activity, measured with the Community Healthy Activities Model Program for Seniors (CHAMPS) physical activity questionnaire<br>3. Quality of life, measured using the 36-item Geriatric Depression Scale (GDS36)<br>4. Body composition, measured by body weight, height, triceps skin-fold thickness<br><br>The primary and secondary outcomes will be measured at baseline, end of intervention and three months post-intervention.