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Selenium and Immune Function

Selenium and Immune Function

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00279812
Enrollment
133
Registered
2006-01-20
Start date
2005-04-30
Completion date
2008-08-31
Last updated
2018-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Immune response, Selenomethionine, Selenium enriched foods, Selenium status, Selenium biomarkers

Brief 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.

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.

Interventions

DIETARY_SUPPLEMENT50ug selenium enriched yeast

Selenomethionine supplement (50ug/d Se) for 12 weeks

DIETARY_SUPPLEMENT100ug selenium enriched yeast

Selenomethionine supplement (100ug/d Se) for 12 weeks

DIETARY_SUPPLEMENT200ug selenium enriched yeast

Selenomethionine supplement (200ug/d Se) for 12 weeks

DIETARY_SUPPLEMENTControl onion

3 meals per week containing un-enriched onion (4ug/d) for 12 weeks

DIETARY_SUPPLEMENTEnriched onion

3 meals per week containing un-enriched onion (50ug/d) for 12 weeks

OTHERPlacebo

Placebo supplement for 12 weeks

Sponsors

Food Standards Agency, United Kingdom
CollaboratorOTHER_GOV
Quadram Institute Bioscience
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
50 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

* Men and women, age 50-64 * Plasma selenium level \<1.2µmol/l (±10%)

Exclusion criteria

* 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. * 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

Design outcomes

Primary

MeasureTime frameDescription
Cellular and Humoral Immune Response12 weeksTotal glutathione peroxidase 1 activity in platelets after supplementation

Secondary

MeasureTime frameDescription
Selenium Status10 weeksPlasma selenium concentration after supplementation
Selenoproteins and Se-biomarkers10 weeksPlasma selenoprotein P after the supllementation

Countries

United Kingdom

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
Placebo
Placebo Selenomethionine (supplement) and selenium enriched onions
20
50ug Selenium Enriched Yeast
Selenomethionine supplement (50ug/d Se) for 12 weeks
20
100ug Selenium Enriched Yeast
Selenomethionine supplement (100ug/d Se) for 12 weeks
21
200ug Selenium Enriched Yeast
Selenomethionine supplement (200ug/d Se) for 12 weeks
23
Control Onion
3 meals per week containing un-enriched onion (4ug/d) for 12 weeks
17
Enriched Onion
3 meals per week containing un-enriched onion (50ug/d) for 12 weeks
18
Total119

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005
Overall StudyAdverse Event011021
Overall StudyProtocol Violation110010
Overall StudyWithdrawal by Subject042000

Baseline characteristics

CharacteristicPlacebo50ug Selenium Enriched Yeast100ug Selenium Enriched Yeast200ug Selenium Enriched YeastControl OnionEnriched OnionTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
20 Participants20 Participants21 Participants23 Participants17 Participants18 Participants119 Participants
Age, Continuous55.8 years
STANDARD_DEVIATION 3.9
56.5 years
STANDARD_DEVIATION 4.6
58.4 years
STANDARD_DEVIATION 3.9
56.1 years
STANDARD_DEVIATION 3.9
58.2 years
STANDARD_DEVIATION 5.1
57.7 years
STANDARD_DEVIATION 4.2
57.12 years
STANDARD_DEVIATION 1.12
BMI25 kg/m^2
STANDARD_DEVIATION 2.7
26.1 kg/m^2
STANDARD_DEVIATION 3
26.3 kg/m^2
STANDARD_DEVIATION 3.9
25.9 kg/m^2
STANDARD_DEVIATION 3.8
26.6 kg/m^2
STANDARD_DEVIATION 4.1
26.1 kg/m^2
STANDARD_DEVIATION 2.4
26 kg/m^2
STANDARD_DEVIATION 0.54
Region of Enrollment
United Kingdom
20 participants20 participants21 participants23 participants17 participants18 participants119 participants
Sex: Female, Male
Female
10 Participants10 Participants11 Participants11 Participants6 Participants6 Participants54 Participants
Sex: Female, Male
Male
10 Participants10 Participants10 Participants12 Participants11 Participants12 Participants65 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
0 / 210 / 260 / 240 / 230 / 200 / 19
other
Total, other adverse events
0 / 211 / 261 / 240 / 232 / 201 / 19
serious
Total, serious adverse events
0 / 210 / 260 / 240 / 230 / 200 / 19

Outcome results

Primary

Cellular and Humoral Immune Response

Total glutathione peroxidase 1 activity in platelets after supplementation

Time frame: 12 weeks

Population: Data from 117 subjects because of incomplete time-course experiment for one subject and baseline plasma selenium concentration for one subject

ArmMeasureValue (MEAN)Dispersion
PlaceboCellular and Humoral Immune Response0.29 umol/minStandard Deviation 0.07
50ug Selenium Enriched YeastCellular and Humoral Immune Response0.34 umol/minStandard Deviation 0.16
100ug Selenium Enriched YeastCellular and Humoral Immune Response0.34 umol/minStandard Deviation 0.15
200ug Selenium Enriched YeastCellular and Humoral Immune Response0.29 umol/minStandard Deviation 0.09
Control OnionCellular and Humoral Immune Response0.35 umol/minStandard Deviation 0.15
Enriched OnionCellular and Humoral Immune Response0.35 umol/minStandard Deviation 0.13
p-value: <0.05ANOVA
Secondary

Selenium Status

Plasma selenium concentration after supplementation

Time frame: 10 weeks

Population: Data from 117 subjects because of incomplete time-course experiment for one subject and baseline plasma selenium concentration for one subject

ArmMeasureValue (MEAN)Dispersion
PlaceboSelenium Status93.7 ng/mLStandard Deviation 16.5
50ug Selenium Enriched YeastSelenium Status118.3 ng/mLStandard Deviation 13.1
100ug Selenium Enriched YeastSelenium Status152.0 ng/mLStandard Deviation 24.3
200ug Selenium Enriched YeastSelenium Status177.4 ng/mLStandard Deviation 26.3
Control OnionSelenium Status94.2 ng/mLStandard Deviation 15
Enriched OnionSelenium Status106.0 ng/mLStandard Deviation 11.9
p-value: 0.05Mixed Models Analysis
Secondary

Selenoproteins and Se-biomarkers

Plasma selenoprotein P after the supllementation

Time frame: 10 weeks

Population: Data from 117 subjects because of incomplete time-course experiment for one subject and baseline plasma selenium concentration for one subject

ArmMeasureValue (MEAN)Dispersion
PlaceboSelenoproteins and Se-biomarkers4.96 ug/mLStandard Deviation 0.86
50ug Selenium Enriched YeastSelenoproteins and Se-biomarkers6.17 ug/mLStandard Deviation 0.85
100ug Selenium Enriched YeastSelenoproteins and Se-biomarkers6.73 ug/mLStandard Deviation 1.01
200ug Selenium Enriched YeastSelenoproteins and Se-biomarkers6.59 ug/mLStandard Deviation 0.64
Control OnionSelenoproteins and Se-biomarkers4.80 ug/mLStandard Deviation 1.03
Enriched OnionSelenoproteins and Se-biomarkers5.72 ug/mLStandard Deviation 0.75
p-value: 0.05Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026