N/A
Completed N=133
Selenium and Immune Function
Healthy
Source: ClinicalTrials.gov NCT00279812 ↗
Enrolled (actual)
133
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcomePrimary: Cellular and Humoral Immune Response — 0.29; 0.34; 0.34; 0.29 umol/min — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cellular and Humoral Immune Response |
0.29; 0.34; 0.34; 0.29; 0.35; 0.35 | <0.05 sig |
| SECONDARY Selenium Status |
93.7; 118.3; 152.0; 177.4; 94.2; 106.0 | 0.05 |
| SECONDARY Selenoproteins and Se-biomarkers |
4.96; 6.17; 6.73; 6.59; 4.80; 5.72 | 0.05 |
Eligibility Criteria
Inclusion Criteria
- Men and women, age 50-64
- Plasma selenium level 160/100)
- Body mass index (BMI) 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
Data sourced from ClinicalTrials.gov (NCT00279812). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.