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Clinical Trials/NCT01224249
NCT01224249
Completed
Phase 1

Selenium Status Measured in Blood After a Higher Intake of Fish and Shellfish - a Randomized Dietary Intervention Study

Danish Cancer Society1 site in 1 country102 target enrollmentAugust 2010

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Selenium Status
Sponsor
Danish Cancer Society
Enrollment
102
Locations
1
Primary Endpoint
Selenium concentration in whole blood
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

The primary aim of this study is to investigate, whether higher intake of selenium rich food items such as fish and shellfish, is associated with higher selenium blood levels.

The secondary aim is to investigate the uptake of selenium from fish and shellfish and the incorporation of selenium from those foods into proteins in the human body. Furthermore, the impact of the natural variation in the genes that are responsible for the accumulation of selenium in the proteins will be investigated.

Detailed Description

Selenium is an essential trace element that is incorporated into proteins in the human body and it hereby plays a major role in several important cellular processes. Previous studies have indicated that the selenium status of the Danish population is below the levels required to optimize the suggested protective effects of selenium towards major diseases including cancer. In Denmark, important natural sources of selenium are fish and shellfish.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
March 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • men and women
  • 50-74 years
  • BMI 18.5-28 kg/m2
  • non-smokers

Exclusion Criteria

  • strenuous exercise \> 10 h/week
  • excessive intake of alcohol
  • frequent intake of fish and shellfish \> 200-300 g/week
  • intake of dietary supplements 3 months before or during the study
  • frequent use of medication except antihypertensive medicine, cholesterol lowering medicine and hormone replacement medicine
  • simultaneous participation in other research projects
  • cancer diagnosis within the past 5 years
  • severe chronic diseases

Outcomes

Primary Outcomes

Selenium concentration in whole blood

Time Frame: Measured after 6 months of intervention

Secondary Outcomes

  • Selenoprotein P in plasma(Measured after 6 months of intervention)
  • Genetic polymorphisms in the selenoprotein P gene(Measured after 6 months of intervention)
  • Heavy metals in whole blood (lead, cadmium, and mercury)(Measured after 6 months of intervention)
  • Blood pressure(Measured after 6 months of intervention)
  • Anthropometry (weight, height, waist, and hip circumference)(Measured after 6 months of intervention)

Study Sites (1)

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