Effect of Fruit and Vegetable Consumption on Immune Function in the Elderly (ADIT)
| Tracking Information | |||||
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| First Received Date ICMJE | March 9, 2009 | ||||
| Last Updated Date | July 22, 2010 | ||||
| Start Date ICMJE | October 2006 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in natural killer cell cytotoxicity and antibody response to Tetanus toxoid and Pneumovax II vaccination [ Time Frame: 16 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00858728 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Change in other markers of immune function [ Time Frame: 16 weeks ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Fruit and Vegetable Consumption on Immune Function in the Elderly | ||||
| Official Title ICMJE | Effect of Fruit and Vegetable Consumption on Immune Function in the Elderly: a Randomised Controlled Trial | ||||
| Brief Summary | The immune system undergoes a range of changes as individuals become elderly. These may manifest as an increasing susceptibility to infection or a tendency to develop autoimmune or malignant disease. Multiple underlying factors contribute to this phenomenon of immunological aging, and in this study the investigators will examine the possibility that inadequate diet may be one such contributing factor. Fruit and vegetable intake, which can be low in the elderly, is associated with reduced chronic disease risk. This proposal will test the hypothesis that increased fruit and vegetable intake may positively affect clinically relevant measures of immune function. One hundred healthy volunteers aged 65-85 years following a low fruit and vegetable diet (<=2 portions/d) will be recruited and randomised to continue following their normal diet, or to consume at least 5 portions of fruit and vegetables daily for 16 weeks. Immune function and biochemical markers of nutritional status will be assessed before and after the intervention period. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Immune Function | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Gibson A, Edgar JD, Neville CE, Gilchrist SE, McKinley MC, Patterson CC, Young IS, Woodside JV. Effect of fruit and vegetable consumption on immune function in older people: a randomized controlled trial. Am J Clin Nutr. 2012 Dec;96(6):1429-36. doi: 10.3945/ajcn.112.039057. Epub 2012 Nov 7. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 83 | ||||
| Completion Date | September 2009 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 65 Years to 85 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00858728 | ||||
| Other Study ID Numbers ICMJE | 06/NIR03/64 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr Jayne Woodside, Queen's University Belfast | ||||
| Study Sponsor ICMJE | Queen's University, Belfast | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Queen's University, Belfast | ||||
| Verification Date | July 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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