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Selenium and Immune Function

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ClinicalTrials.gov Identifier: NCT00279812
Recruitment Status : Completed
First Posted : January 20, 2006
Results First Posted : July 16, 2018
Last Update Posted : July 16, 2018
Sponsor:
Collaborator:
Food Standards Agency, United Kingdom
Information provided by (Responsible Party):
Quadram Institute

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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: 50ug selenium enriched yeast Dietary Supplement: 100ug selenium enriched yeast Dietary Supplement: 200ug selenium enriched yeast Dietary Supplement: Control onion Dietary Supplement: Enriched onion Other: Placebo Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
Official Title: Selenium and Immune Function
Study Start Date : April 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Other: Placebo
Placebo supplement for 12 weeks

Experimental: 50ug selenium enriched yeast
50ug/d selenium enriched yeast (containing 60% selenomethionine)
Dietary Supplement: 50ug selenium enriched yeast
Selenomethionine supplement (50ug/d Se) for 12 weeks

Experimental: 100ug selenium enriched yeast
100ug/d selenium enriched yeast (containing 60% selenomethionine)
Dietary Supplement: 100ug selenium enriched yeast
Selenomethionine supplement (100ug/d Se) for 12 weeks

Experimental: 200ug selenium enriched yeast
200ug/d selenium enriched yeast (containing 60% selenomethionine)
Dietary Supplement: 200ug selenium enriched yeast
Selenomethionine supplement (200ug/d Se) for 12 weeks

Experimental: Control onion
3 meals/wk containing un-enriched onions equivalent to 4ug/d Se
Dietary Supplement: Control onion
3 meals per week containing un-enriched onion (4ug/d) for 12 weeks

Experimental: Enriched onion
3 meals/wk containing enriched onions equivalent to 50ug/d Se
Dietary Supplement: Enriched onion
3 meals per week containing un-enriched onion (50ug/d) for 12 weeks




Primary Outcome Measures :
  1. Cellular and Humoral Immune Response [ Time Frame: 12 weeks ]
    Total glutathione peroxidase 1 activity in platelets after supplementation


Secondary Outcome Measures :
  1. Selenium Status [ Time Frame: 10 weeks ]
    Plasma selenium concentration after supplementation

  2. Selenoproteins and Se-biomarkers [ Time Frame: 10 weeks ]
    Plasma selenoprotein P after the supllementation



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Ages Eligible for Study:   50 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00279812


Locations
United Kingdom
Institute of Food Research
Norwich, Norfolk, United Kingdom, NR4 7UA
Sponsors and Collaborators
Quadram Institute
Food Standards Agency, United Kingdom
Investigators
Principal Investigator: Susan J Fairweather-Tait, PhD University of East Anglia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Quadram Institute
ClinicalTrials.gov Identifier: NCT00279812     History of Changes
Other Study ID Numbers: IFR02/2005
FSA 51949F ( Other Identifier: Food Standards Agency )
First Posted: January 20, 2006    Key Record Dates
Results First Posted: July 16, 2018
Last Update Posted: July 16, 2018
Last Verified: September 2017

Keywords provided by Quadram Institute:
Immune response
Selenomethionine
Selenium enriched foods
Selenium status
Selenium biomarkers

Additional relevant MeSH terms:
Selenium
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances