NCT00279812

Selenium and Immune Function

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Quadram Institute Bioscience · Academic / Other
• Sex: All
• Age: 50 Years – 64 Years
• Healthy volunteers: Accepted

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-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.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	50ug selenium enriched yeast	Selenomethionine supplement (50ug/d Se) for 12 weeks
DIETARY_SUPPLEMENT	100ug selenium enriched yeast	Selenomethionine supplement (100ug/d Se) for 12 weeks
DIETARY_SUPPLEMENT	200ug selenium enriched yeast	Selenomethionine supplement (200ug/d Se) for 12 weeks
DIETARY_SUPPLEMENT	Control onion	3 meals per week containing un-enriched onion (4ug/d) for 12 weeks
DIETARY_SUPPLEMENT	Enriched onion	3 meals per week containing un-enriched onion (50ug/d) for 12 weeks
OTHER	Placebo	Placebo supplement for 12 weeks

Timeline

• Start date: 2005-04-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2006-01-20
• Last updated: 2018-07-16
• Results posted: 2018-07-16

Locations

1 site across 1 country: United Kingdom