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Completed

NCT Number: NCT01224249

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

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.

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Key information

Conditions

Selenium Status Selenium Uptake From Fish and Shellfish

Age range

50 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Institute of Cancer Epidemiology, Danish Cancer Society

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fish and shellfish

Dietary Supplement

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

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

Sponsors and collaborators

Lead sponsor

Danish Cancer Society

Other

Collaborators

  • Danish Shellfish Center
  • Technical University of Denmark

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 20, 2010
Registry last updated
Sep 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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