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| ID | Type | Description | Link |
|---|---|---|---|
| FSA 51949F | Other Identifier | Food Standards Agency |
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| Name | Class |
|---|---|
| Food Standards Agency, United Kingdom | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| 50ug selenium enriched yeast | Experimental | 50ug/d selenium enriched yeast (containing 60% selenomethionine) |
|
| 100ug selenium enriched yeast | Experimental | 100ug/d selenium enriched yeast (containing 60% selenomethionine) |
|
| 200ug selenium enriched yeast | Experimental | 200ug/d selenium enriched yeast (containing 60% selenomethionine) |
|
| Control onion | Experimental | 3 meals/wk containing un-enriched onions equivalent to 4ug/d Se |
|
| Enriched onion | Experimental | 3 meals/wk containing enriched onions equivalent to 50ug/d Se |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 50ug selenium enriched yeast | Dietary Supplement | Selenomethionine supplement (50ug/d Se) for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cellular and Humoral Immune Response | Total glutathione peroxidase 1 activity in platelets after supplementation | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Selenium Status | Plasma selenium concentration after supplementation | 10 weeks |
| Selenoproteins and Se-biomarkers | Plasma selenoprotein P after the supllementation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan J Fairweather-Tait, PhD | University of East Anglia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Food Research | Norwich | Norfolk | NR4 7UA | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26803169 | Derived | 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. | |
| 21445287 | Derived | 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. |
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Recruitment ran from May until the following February in 2005, 2006, and 2007. Study completed in June 2008. 272 volunteers completed a screening questionnaire,182 volunteers had blood samples screened, total of 133 were recruited and 119 completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo Selenomethionine (supplement) and selenium enriched onions |
| FG001 | 50ug Selenium Enriched Yeast | Selenomethionine supplement (50ug/d Se) for 12 weeks |
| FG002 | 100ug Selenium Enriched Yeast | Selenomethionine supplement (100ug/d Se) for 12 weeks |
| FG003 | 200ug Selenium Enriched Yeast | Selenomethionine supplement (200ug/d Se) for 12 weeks |
| FG004 | Control Onion | 3 meals per week containing un-enriched onion (4ug/d) for 12 weeks |
| FG005 | Enriched Onion | 3 meals per week containing un-enriched onion (50ug/d) for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo Selenomethionine (supplement) and selenium enriched onions |
| BG001 | 50ug Selenium Enriched Yeast | Selenomethionine supplement (50ug/d Se) for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cellular and Humoral Immune Response | Total glutathione peroxidase 1 activity in platelets after supplementation | Data from 117 subjects because of incomplete time-course experiment for one subject and baseline plasma selenium concentration for one subject | Posted | Mean | Standard Deviation | umol/min | 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo Selenomethionine (supplement) and selenium enriched onions | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cold symptoms | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Charlotte Armah | Institute of Food Research | 01603 255 000 | 5360 | charlotte.armah@ifr.ac.uk |
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|
| 100ug selenium enriched yeast | Dietary Supplement | Selenomethionine supplement (100ug/d Se) for 12 weeks |
|
| 200ug selenium enriched yeast | Dietary Supplement | Selenomethionine supplement (200ug/d Se) for 12 weeks |
|
| Control onion | Dietary Supplement | 3 meals per week containing un-enriched onion (4ug/d) for 12 weeks |
|
| Enriched onion | Dietary Supplement | 3 meals per week containing un-enriched onion (50ug/d) for 12 weeks |
|
| Placebo | Other | Placebo supplement for 12 weeks |
|
| 10 weeks |
| 20181815 | Derived | 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. |
| Withdrawal by Subject |
|
| Adverse Event |
|
| BG002 | 100ug Selenium Enriched Yeast | Selenomethionine supplement (100ug/d Se) for 12 weeks |
| BG003 | 200ug Selenium Enriched Yeast | Selenomethionine supplement (200ug/d Se) for 12 weeks |
| BG004 | Control Onion | 3 meals per week containing un-enriched onion (4ug/d) for 12 weeks |
| BG005 | Enriched Onion | 3 meals per week containing un-enriched onion (50ug/d) for 12 weeks |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| 100ug Selenium Enriched Yeast |
Selenomethionine supplement (100ug/d Se) for 12 weeks |
| OG003 | 200ug Selenium Enriched Yeast | Selenomethionine supplement (200ug/d Se) for 12 weeks |
| OG004 | Control Onion | 3 meals per week containing un-enriched onion (4ug/d) for 12 weeks |
| OG005 | Enriched Onion | 3 meals per week containing un-enriched onion (50ug/d) for 12 weeks |
|
|
|
| Secondary | Selenium Status | Plasma selenium concentration after supplementation | Data from 117 subjects because of incomplete time-course experiment for one subject and baseline plasma selenium concentration for one subject | Posted | Mean | Standard Deviation | ng/mL | 10 weeks |
|
|
|
|
| Secondary | Selenoproteins and Se-biomarkers | Plasma selenoprotein P after the supllementation | Data from 117 subjects because of incomplete time-course experiment for one subject and baseline plasma selenium concentration for one subject | Posted | Mean | Standard Deviation | ug/mL | 10 weeks |
|
|
|
|
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | 50ug Selenium Enriched Yeast | Selenomethionine supplement (50ug/d Se) for 12 weeks | 0 | 26 | 0 | 26 | 1 | 26 |
| EG002 | 100ug Selenium Enriched Yeast | Selenomethionine supplement (100ug/d Se) for 12 weeks | 0 | 24 | 0 | 24 | 1 | 24 |
| EG003 | 200ug Selenium Enriched Yeast | Selenomethionine supplement (200ug/d Se) for 12 weeks | 0 | 23 | 0 | 23 | 0 | 23 |
| EG004 | Control Onion | 3 meals per week containing un-enriched onion (4ug/d) for 12 weeks | 0 | 20 | 0 | 20 | 2 | 20 |
| EG005 | Enriched Onion | 3 meals per week containing un-enriched onion (50ug/d) for 12 weeks | 0 | 19 | 0 | 19 | 1 | 19 |
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