N/A
N=133
Selenium and Immune Function
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT00279812 ↗Enrolled (actual)
133
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Cellular and Humoral Immune Response — 0.29; 0.34; 0.34; 0.29 umol/min — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 50ug selenium enriched yeast (Dietary_supplement); 100ug selenium enriched yeast (Dietary_supplement); 200ug selenium enriched yeast (Dietary_supplement); Control onion (Dietary_supplement); Enriched onion (Dietary_supplement); Placebo (Other)
- Age
- Adult · 50+ yrs
- Sex
- All
- Sponsor
- Quadram Institute Bioscience
- Primary completion
- Aug 2008
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 |
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.
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.