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

September 28, 2011 updated by: Danish Cancer Society

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Institute of Cancer Epidemiology, Danish Cancer Society

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Selenium concentration in whole blood
Time Frame: Measured at baseline
Measured at baseline
Selenium concentration in whole blood
Time Frame: Measured after 3 months of intervention
Measured after 3 months of intervention
Selenium concentration in whole blood
Time Frame: Measured after 6 months of intervention
Measured after 6 months of intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Selenoprotein P in plasma
Time Frame: Measured at baseline
Measured at baseline
Selenoprotein P in plasma
Time Frame: Measured after 3 months of intervention
Measured after 3 months of intervention
Selenoprotein P in plasma
Time Frame: Measured after 6 months of intervention
Measured after 6 months of intervention
Genetic polymorphisms in the selenoprotein P gene
Time Frame: Measured at baseline
Measured at baseline
Genetic polymorphisms in the selenoprotein P gene
Time Frame: Measured after 3 months of intervention
Measured after 3 months of intervention
Genetic polymorphisms in the selenoprotein P gene
Time Frame: Measured after 6 months of intervention
Measured after 6 months of intervention
Heavy metals in whole blood (lead, cadmium, and mercury)
Time Frame: Measured at baseline
Measured at baseline
Heavy metals in whole blood (lead, cadmium, and mercury)
Time Frame: Measured after 3 months of intervention
Measured after 3 months of intervention
Heavy metals in whole blood (lead, cadmium, and mercury)
Time Frame: Measured after 6 months of intervention
Measured after 6 months of intervention
Blood pressure
Time Frame: Measured at baseline
Measured at baseline
Blood pressure
Time Frame: Measured after 3 months of intervention
Measured after 3 months of intervention
Blood pressure
Time Frame: Measured after 6 months of intervention
Measured after 6 months of intervention
Anthropometry (weight, height, waist, and hip circumference)
Time Frame: Measured at baseline
Measured at baseline
Anthropometry (weight, height, waist, and hip circumference)
Time Frame: Measured after 3 months of intervention
Measured after 3 months of intervention
Anthropometry (weight, height, waist, and hip circumference)
Time Frame: Measured after 6 months of intervention
Measured after 6 months of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Cancer Society

Collaborators

Technical University of Denmark
Danish Shellfish Center

Investigators

  • Principal Investigator: Anne Tjonneland, professor, M.D., Ph.D., Institute of Cancer Epidemiology, Danish Cancer Society

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

October 18, 2010

First Submitted That Met QC Criteria

October 19, 2010

First Posted (Estimate)

October 20, 2010

Study Record Updates

Last Update Posted (Estimate)

September 29, 2011

Last Update Submitted That Met QC Criteria

September 28, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DCS-53227244

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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