HealthyNCT00279812
Selenium and Immune Function
A study testing 50ug selenium enriched yeast, 100ug selenium enriched yeast and 200ug selenium enriched yeast in people with Healthy, run by Quadram Institute Bioscience at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 50ug selenium enriched yeast, 100ug selenium enriched yeast and 200ug selenium enriched yeast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2005to Aug 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women, age 50-64
- Plasma selenium level <1.2µmol/l (±10%)
Who cannot join
- Elevated blood pressure measurements (<90/50 or <95/50 if symptomatic or >160/100)
- 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.
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Food Research
Norwich, Norfolk, NR4 7UA
About this study
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.
Read the detailed description
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.
- Conditions
- Healthy
- Being tested
- 50ug selenium enriched yeast, 100ug selenium enriched yeast, 200ug selenium enriched yeast, Control onion, Enriched onion
- Keywords
- Immune response, Selenomethionine, Selenium enriched foods, Selenium status, Selenium biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50ug selenium enriched yeastDietary supplement
Selenomethionine supplement (50ug/d Se) for 12 weeks
100ug selenium enriched yeastDietary supplement
Selenomethionine supplement (100ug/d Se) for 12 weeks
200ug selenium enriched yeastDietary supplement
Selenomethionine supplement (200ug/d Se) for 12 weeks
Control onionDietary supplement
3 meals per week containing un-enriched onion (4ug/d) for 12 weeks
Enriched onionDietary supplement
3 meals per week containing un-enriched onion (50ug/d) for 12 weeks
PlaceboOther
Placebo supplement for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
| 50ug selenium enriched yeast | Experimental | 50ug/d selenium enriched yeast (containing 60% selenomethionine) Receives: Dietary Supplement: 50ug selenium enriched yeast |
| 100ug selenium enriched yeast | Experimental | 100ug/d selenium enriched yeast (containing 60% selenomethionine) Receives: Dietary Supplement: 100ug selenium enriched yeast |
| 200ug selenium enriched yeast | Experimental | 200ug/d selenium enriched yeast (containing 60% selenomethionine) Receives: Dietary Supplement: 200ug selenium enriched yeast |
| Control onion | Experimental | 3 meals/wk containing un-enriched onions equivalent to 4ug/d Se Receives: Dietary Supplement: Control onion |
| Enriched onion | Experimental | 3 meals/wk containing enriched onions equivalent to 50ug/d Se Receives: Dietary Supplement: Enriched onion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cellular and Humoral Immune Response
Total glutathione peroxidase 1 activity in platelets after supplementation
Measured: 12 weeks
Secondary outcomes (2)
Selenium Status
Plasma selenium concentration after supplementation
Measured: 10 weeks
Selenoproteins and Se-biomarkers
Plasma selenoprotein P after the supllementation
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2006 (estimated)
- Study startApr 2005
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quadram Institute Bioscience
- Sponsor type
- University, hospital or other
- Collaborators
- Food Standards Agency, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Susan J Fairweather-Tait, PhD, Principal investigator, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279812
- Sponsor's protocol ID
- IFR02/2005
- Other IDs
- FSA 51949F
- Status last verified
- Sep 2017
- First submitted
- 19 Jan 2006
- Last updated
- 16 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 26803169Goldson 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.
PubMed 21445287Hurst 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.
PubMed 20181815
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selenium and Immune Function
- ClinicalTrials.gov ID
- NCT00279812
- Acronym / sponsor ID
- IFR02/2005
- Conditions
- Healthy
- Keywords
- Immune response, Selenomethionine, Selenium enriched foods, Selenium status, Selenium biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Quadram Institute BioscienceUniversity, hospital or other
- Collaborators
- Food Standards Agency, United Kingdom
- Study start
- Apr 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 20 Jan 2006 (estimated)
- Results
- Posted 16 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
| 50ug selenium enriched yeast | Experimental | Dietary Supplement: 50ug selenium enriched yeast50ug/d selenium enriched yeast (containing 60% selenomethionine) |
| 100ug selenium enriched yeast | Experimental | Dietary Supplement: 100ug selenium enriched yeast100ug/d selenium enriched yeast (containing 60% selenomethionine) |
| 200ug selenium enriched yeast | Experimental | Dietary Supplement: 200ug selenium enriched yeast200ug/d selenium enriched yeast (containing 60% selenomethionine) |
| Control onion | Experimental | Dietary Supplement: Control onion3 meals/wk containing un-enriched onions equivalent to 4ug/d Se |
| Enriched onion | Experimental | Dietary Supplement: Enriched onion3 meals/wk containing enriched onions equivalent to 50ug/d Se |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men and women, age 50-64
- Plasma selenium level <1.2µmol/l (±10%)
Key exclusion criteria (21 listed)
- Elevated blood pressure measurements (<90/50 or <95/50 if symptomatic or >160/100)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 50ug selenium enriched yeastSelenomethionine supplement (50ug/d Se) for 12 weeks | Dietary supplement | 50ug selenium enriched yeast |
| 100ug selenium enriched yeastSelenomethionine supplement (100ug/d Se) for 12 weeks | Dietary supplement | 100ug selenium enriched yeast |
| 200ug selenium enriched yeastSelenomethionine supplement (200ug/d Se) for 12 weeks | Dietary supplement | 200ug selenium enriched yeast |
| Control onion3 meals per week containing un-enriched onion (4ug/d) for 12 weeks | Dietary supplement | Control onion |
| Enriched onion3 meals per week containing un-enriched onion (50ug/d) for 12 weeks | Dietary supplement | Enriched onion |
| PlaceboPlacebo supplement for 12 weeks | Other | Placebo |
Primary outcome
Cellular and Humoral Immune Response
Time frame: 12 weeks
Total glutathione peroxidase 1 activity in platelets after supplementation
2 secondary outcomes
Selenium Status
Time frame: 10 weeks
Selenoproteins and Se-biomarkers
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26803169Ivory 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.
- Derived from this study: PubMed 21445287Goldson 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.
- Derived from this study: PubMed 20181815Hurst 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan J Fairweather-Tait, PhD principal investigator
University of East Anglia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 50ug selenium enriched yeast, 100ug selenium enriched yeast and 200ug selenium enriched yeast in people with Healthy, run by Quadram Institute Bioscience at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cellular and Humoral Immune Response (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00279812, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2018.