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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Selenium Status
Selenium Uptake From Fish and Shellfish
 Dietary Supplement: Fish and shellfish
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Selenium Status Measured in Blood After a Higher Intake of Fish and Shellfish - a Randomized Dietary Intervention Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Danish Cancer Society:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 102
Study Start Date: August 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fish and shellfish Dietary Supplement: Fish and shellfish
Intake of 1000 grams of fish and shellfish per week for six months.
No Intervention: Control
Assessment only

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.

  Eligibility

Ages Eligible for Study:   50 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224249

Locations
Denmark
Institute of Cancer Epidemiology, Danish Cancer Society
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Danish Cancer Society
Technical University of Denmark
Danish Shellfish Center
Investigators
Principal Investigator: Anne Tjonneland, professor, M.D., Ph.D. Institute of Cancer Epidemiology, Danish Cancer Society
  More Information

No publications provided

Responsible Party: Anne Tjønneland, professor, M.D., Ph.D., Institute of Cancer Epidemiology, Danish Cancer Society
ClinicalTrials.gov Identifier: NCT01224249     History of Changes
Other Study ID Numbers: DCS-53227244
Study First Received: October 18, 2010
Last Updated: September 28, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Danish Cancer Society:
Selenium
Selenoprotein P
Fish
Shellfish
Bioavailability

Additional relevant MeSH terms:
Selenium
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
 Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013