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CompletedNCT01224249Updated Sep 29, 2011

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

A Phase 1 interventional study of Fish and shellfish in Selenium Status and Selenium Uptake From Fish and Shellfish, sponsored by Danish Cancer Society. Completed at 1 site in Denmark. Open to participants aged 50 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-09-29.

Sponsored by Danish Cancer Society · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
50 Years to 74 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Selenium Status
  • Selenium Uptake From Fish and Shellfish

Keywords

  • Selenium
  • Selenoprotein P
  • Fish
  • Shellfish
  • Bioavailability
03

In context

Lead sponsor

Danish Cancer Society is the lead sponsor of 22 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
102 participants (actual)

Study arms

  • Active comparator
    Fish and shellfish

    Dietary Supplement: Fish and shellfish

  • No intervention
    Control

    Assessment only

Interventions

  • Dietary supplementFish and shellfish

    Intake of 1000 grams of fish and shellfish per week for six months.

06

What researchers measure

Primary outcomes

  1. Selenium concentration in whole blood

    Time frame: Measured at baseline

  2. Selenium concentration in whole blood

    Time frame: Measured after 3 months of intervention

  3. Selenium concentration in whole blood

    Time frame: Measured after 6 months of intervention

Secondary outcomes

  1. Selenoprotein P in plasma

    Time frame: Measured at baseline

  2. Selenoprotein P in plasma

    Time frame: Measured after 3 months of intervention

  3. Selenoprotein P in plasma

    Time frame: Measured after 6 months of intervention

  4. Genetic polymorphisms in the selenoprotein P gene

    Time frame: Measured at baseline

  5. Genetic polymorphisms in the selenoprotein P gene

    Time frame: Measured after 3 months of intervention

  6. Genetic polymorphisms in the selenoprotein P gene

    Time frame: Measured after 6 months of intervention

  7. Heavy metals in whole blood (lead, cadmium, and mercury)

    Time frame: Measured at baseline

  8. Heavy metals in whole blood (lead, cadmium, and mercury)

    Time frame: Measured after 3 months of intervention

  9. Heavy metals in whole blood (lead, cadmium, and mercury)

    Time frame: Measured after 6 months of intervention

  10. Blood pressure

    Time frame: Measured at baseline

  11. Blood pressure

    Time frame: Measured after 3 months of intervention

  12. Blood pressure

    Time frame: Measured after 6 months of intervention

  13. Anthropometry (weight, height, waist, and hip circumference)

    Time frame: Measured at baseline

  14. Anthropometry (weight, height, waist, and hip circumference)

    Time frame: Measured after 3 months of intervention

  15. Anthropometry (weight, height, waist, and hip circumference)

    Time frame: Measured after 6 months of intervention

07

Study locations

1 site
  • Institute of Cancer Epidemiology, Danish Cancer Society
    Copenhagen, 2100, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01224249
Lead sponsor
Danish Cancer Society
Collaborators
Technical University of Denmark, Danish Shellfish Center
First posted
Oct 20, 2010
Start date
Aug 2010
Primary completion
Mar 2011
Completion
Mar 2011
Last update
Sep 29, 2011

Study contacts

Anne Tjonneland, professor, M.D., Ph.D.
principal investigator · Institute of Cancer Epidemiology, Danish Cancer Society

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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