Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT00279812
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
64 Years
Study:
NCT00279812
Study Brief:
Protocol Section:
NCT00279812