Study Results
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View full resultsBasic Information
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COMPLETED
NA
133 participants
INTERVENTIONAL
2005-04-30
2008-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Placebo
Placebo
Placebo
Placebo supplement for 12 weeks
50ug selenium enriched yeast
50ug/d selenium enriched yeast (containing 60% selenomethionine)
50ug selenium enriched yeast
Selenomethionine supplement (50ug/d Se) for 12 weeks
100ug selenium enriched yeast
100ug/d selenium enriched yeast (containing 60% selenomethionine)
100ug selenium enriched yeast
Selenomethionine supplement (100ug/d Se) for 12 weeks
200ug selenium enriched yeast
200ug/d selenium enriched yeast (containing 60% selenomethionine)
200ug selenium enriched yeast
Selenomethionine supplement (200ug/d Se) for 12 weeks
Control onion
3 meals/wk containing un-enriched onions equivalent to 4ug/d Se
Control onion
3 meals per week containing un-enriched onion (4ug/d) for 12 weeks
Enriched onion
3 meals/wk containing enriched onions equivalent to 50ug/d Se
Enriched onion
3 meals per week containing un-enriched onion (50ug/d) for 12 weeks
Interventions
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50ug selenium enriched yeast
Selenomethionine supplement (50ug/d Se) for 12 weeks
100ug selenium enriched yeast
Selenomethionine supplement (100ug/d Se) for 12 weeks
200ug selenium enriched yeast
Selenomethionine supplement (200ug/d Se) for 12 weeks
Control onion
3 meals per week containing un-enriched onion (4ug/d) for 12 weeks
Enriched onion
3 meals per week containing un-enriched onion (50ug/d) for 12 weeks
Placebo
Placebo supplement for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Plasma selenium level \<1.2µmol/l (±10%)
Exclusion Criteria
* Body mass index (BMI) \<18.5 or \>35
* Results of the clinical screening which are judged by the Human Nutrition Unit (HNU) Medical advisor to be indicative of a health problem and could compromise the well-being of the volunteer if they participated, or which would affect the data.
* Smokers
* Diagnosed with gastrointestinal disease (excluding hiatus hernia unless symptomatic or study intervention/procedure is contraindicated) for which they have been taking prescription drugs on a chronic basis.
* Diagnosed with a long-term illness requiring active treatment, e.g. diabetes, cancer, cardiovascular disease.
* On regularly prescribed medication known to have a profound effect on the immune function
* Regularly using antacids and laxatives (at least once a week)
* Sufferers of hay-fever taking regular steroid medication
* Unwillingness to discontinue dietary (other than vitamins and minerals) or herbal supplements less than one month prior to the start of the study and for the duration of the study
* Blood donation within 16 weeks of the first study sample and who intend to donate blood less than 16 weeks after the last study sample
* Antibiotic use within four weeks prior to starting the study
* Those who receive or plan to receive any other type of immunisation during the study period
* Those who have received an immunisation within 6 months of the start of the study
* Intention to go on holiday/trips for more than 2 weeks during the twelve week intervention
* Those planning a holiday/trip that requires immunisation during the twelve week intervention period
* Parallel participation in another research project which involves dietary intervention or sampling of biological fluids/materials
* Allergic to eggs or egg products
* Allergic to chicken protein
* Allergic to the antibiotic Gentamicin
* A history of Guillain-Barre syndrome
50 Years
64 Years
ALL
Yes
Sponsors
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Food Standards Agency, United Kingdom
OTHER_GOV
Quadram Institute Bioscience
OTHER
Responsible Party
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Principal Investigators
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Susan J Fairweather-Tait, PhD
Role: PRINCIPAL_INVESTIGATOR
University of East Anglia
Locations
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Institute of Food Research
Norwich, Norfolk, United Kingdom
Countries
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References
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Ivory K, Prieto E, Spinks C, Armah CN, Goldson AJ, Dainty JR, Nicoletti C. Selenium supplementation has beneficial and detrimental effects on immunity to influenza vaccine in older adults. Clin Nutr. 2017 Apr;36(2):407-415. doi: 10.1016/j.clnu.2015.12.003. Epub 2015 Dec 24.
Goldson AJ, Fairweather-Tait SJ, Armah CN, Bao Y, Broadley MR, Dainty JR, Furniss C, Hart DJ, Teucher B, Hurst R. Effects of selenium supplementation on selenoprotein gene expression and response to influenza vaccine challenge: a randomised controlled trial. PLoS One. 2011 Mar 21;6(3):e14771. doi: 10.1371/journal.pone.0014771.
Hurst R, Armah CN, Dainty JR, Hart DJ, Teucher B, Goldson AJ, Broadley MR, Motley AK, Fairweather-Tait SJ. Establishing optimal selenium status: results of a randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2010 Apr;91(4):923-31. doi: 10.3945/ajcn.2009.28169. Epub 2010 Feb 24.
Other Identifiers
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FSA 51949F
Identifier Type: OTHER
Identifier Source: secondary_id
IFR02/2005
Identifier Type: -
Identifier Source: org_study_id
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