Status:
COMPLETED
Selenium and Immune Function
Lead Sponsor:
Quadram Institute Bioscience
Collaborating Sponsors:
Food Standards Agency, United Kingdom
Conditions:
Healthy
Eligibility:
All Genders
50-64 years
Phase:
NA
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-bas...
Eligibility Criteria
Inclusion
- Men and women, age 50-64
- Plasma selenium level \<1.2µmol/l (±10%)
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT00279812
Start Date
April 1 2005
End Date
August 1 2008
Last Update
July 16 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institute of Food Research
Norwich, Norfolk, United Kingdom, NR4 7UA