Selenium and Immune Function

September 28, 2017 updated by: Quadram Institute Bioscience
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

133

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UA
        • Institute of Food Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cellular and Humoral Immune Response
Time Frame: 12 weeks
Total glutathione peroxidase 1 activity in platelets after supplementation
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Selenium Status
Time Frame: 10 weeks
Plasma selenium concentration after supplementation
10 weeks
Selenoproteins and Se-biomarkers
Time Frame: 10 weeks
Plasma selenoprotein P after the supllementation
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quadram Institute Bioscience

Collaborators

Food Standards Agency, United Kingdom

Investigators

  • Principal Investigator: Susan J Fairweather-Tait, PhD, University of East Anglia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

January 19, 2006

First Submitted That Met QC Criteria

January 19, 2006

First Posted (Estimate)

January 20, 2006

Study Record Updates

Last Update Posted (Actual)

July 16, 2018

Last Update Submitted That Met QC Criteria

September 28, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFR02/2005
  • FSA 51949F (Other Identifier: Food Standards Agency)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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