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

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2007
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. CONDITION: This study looks at immune function in healthy subjects ; Nutritional, Metabolic, Endocrine ; Immune function and nutrition PRIMARY OUTCOME: 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: 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. 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)
Epistemonikos ID: fc762dc8cbe85f336a3ce6c9a386ef9b13892abf
First added on: Aug 21, 2024