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Sponsors and Collaborators: |
Institute of Food Research Food Standards Agency, United Kingdom |
Information provided by: | Institute of Food Research |
ClinicalTrials.gov Identifier: | NCT00279812 |
The aim of the study is to investigate the relationship between dose and form of selenium on immune function, and to identify functional markers of selenium status.
Condition | Intervention |
Healthy |
Behavioral: Selenomethionine (supplement) and selenium enriched onions |
Drug Information available for: | Selenium Selenomethionine |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Selenium and Immune Function |
Estimated Enrollment: | 144 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | February 2008 |
One of the proposed consequences of marginal selenium status is impaired immune function. Establishing the potential role of selenium as an enhancer of immune response in vivo may provide evidence-base for public health policy, with important consequences for preventing influenza and similar diseases in the elderly.
The project consists of a placebo controlled selenium supplementation study and a dietary intervention with un-enriched and selenium enriched onions. In a parallel group design, subjects will be given either one of three doses of Selenomethionine (50, 100 or 200µg selenium/day) or a placebo per day or selenium enriched or un-enriched onions (in the form of test meals) for 12 weeks. Changes in the expression of Se-responsive genes and proteins in blood will be measured and compared with changes in plasma Se concentration and selected selenoproteins. The relationship between dietary Se intake and systemic and mucosal immune responses to influenza vaccine will be examined. Changes in immune cell populations and the influence of Se on NK and CD8 cytotoxicity will be determined by flow cytometry.
Ages Eligible for Study: | 50 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Susan J Fairweather-Tait, BSc., MSc., PhD., DSc | +44 1603 255306 ext 5336 | sue.fairweather-tait@bbsrc.ac.uk |
Contact: Birgit Teucher, Dipl.oec.troph., PhD | +44 1603 255304 ext 5304 | birgit.teucher@bbsrc.ac.uk |
United Kingdom, Norfolk | |||||
Institute of Food Research | Recruiting | ||||
Norwich, Norfolk, United Kingdom, NR4 7UA |
Institute of Food Research |
Food Standards Agency, United Kingdom |
Principal Investigator: | Susan J Fairweather-Tait, BSc., MSc., PhD., DSc | Institute of Food Research |
Click here for more information about the study 
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Study ID Numbers: | IFR02/2005, FSA 51949F |
First Received: | January 19, 2006 |
Last Updated: | October 12, 2006 |
ClinicalTrials.gov Identifier: | NCT00279812 |
Health Authority: | United Kingdom: National Health Service |
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