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

This study has been completed.
Sponsor:
Collaborators:
Technical University of Denmark
Danish Shellfish Center
Information provided by:
Danish Cancer Society
ClinicalTrials.gov Identifier:
NCT01224249
First received: October 18, 2010
Last updated: September 28, 2011
Last verified: August 2011

October 18, 2010
September 28, 2011
August 2010
March 2011   (final data collection date for primary outcome measure)
  • Selenium concentration in whole blood [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
  • Selenium concentration in whole blood [ Time Frame: Measured after 3 months of intervention ] [ Designated as safety issue: No ]
  • Selenium concentration in whole blood [ Time Frame: Measured after 6 months of intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01224249 on ClinicalTrials.gov Archive Site
  • Selenoprotein P in plasma [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
  • Selenoprotein P in plasma [ Time Frame: Measured after 3 months of intervention ] [ Designated as safety issue: No ]
  • Selenoprotein P in plasma [ Time Frame: Measured after 6 months of intervention ] [ Designated as safety issue: No ]
  • Genetic polymorphisms in the selenoprotein P gene [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
  • Genetic polymorphisms in the selenoprotein P gene [ Time Frame: Measured after 3 months of intervention ] [ Designated as safety issue: No ]
  • Genetic polymorphisms in the selenoprotein P gene [ Time Frame: Measured after 6 months of intervention ] [ Designated as safety issue: No ]
  • Heavy metals in whole blood (lead, cadmium, and mercury) [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
  • Heavy metals in whole blood (lead, cadmium, and mercury) [ Time Frame: Measured after 3 months of intervention ] [ Designated as safety issue: No ]
  • Heavy metals in whole blood (lead, cadmium, and mercury) [ Time Frame: Measured after 6 months of intervention ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: Measured after 3 months of intervention ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: Measured after 6 months of intervention ] [ Designated as safety issue: No ]
  • Anthropometry (weight, height, waist, and hip circumference) [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
  • Anthropometry (weight, height, waist, and hip circumference) [ Time Frame: Measured after 3 months of intervention ] [ Designated as safety issue: No ]
  • Anthropometry (weight, height, waist, and hip circumference) [ Time Frame: Measured after 6 months of intervention ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Selenium Status Measured in Blood After a Higher Intake of Fish and Shellfish - a Randomized Dietary Intervention Study
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Selenium Status
  • Selenium Uptake From Fish and Shellfish
Dietary Supplement: Fish and shellfish
Intake of 1000 grams of fish and shellfish per week for six months.
  • Active Comparator: Fish and shellfish
    Intervention: Dietary Supplement: Fish and shellfish
  • No Intervention: Control
    Assessment only
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
50 Years to 74 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01224249
DCS-53227244
Yes
Anne Tjønneland, professor, M.D., Ph.D., Institute of Cancer Epidemiology, Danish Cancer Society
Danish Cancer Society
  • Technical University of Denmark
  • Danish Shellfish Center
Principal Investigator: Anne Tjonneland, professor, M.D., Ph.D. Institute of Cancer Epidemiology, Danish Cancer Society
Danish Cancer Society
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP