Clinical trial NCT01224249: Selenium Status Measured in Blood After a Higher Intake of Fish and Shellfish - a Randomized Dietary Intervention Study
Official title: Selenium Status Measured in Blood After a Higher Intake of Fish and Shellfish - a Randomized Dietary Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Selenium Status
Selenium Uptake From Fish and Shellfish
Keywords: Selenium
Selenoprotein P
Fish
Shellfish
Bioavailability
Lead sponsor: Danish Cancer Society
Sponsor class: OTHER
Collaborators: name: Technical University of Denmark
name: Danish Shellfish Center
First posted: 2010-10-20
Enrollment: 102
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

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 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

Primary outcomes:
measure: Selenium concentration in whole blood
timeFrame: Measured at baseline
measure: Selenium concentration in whole blood
timeFrame: Measured after 3 months of intervention
measure: Selenium concentration in whole blood
timeFrame: Measured after 6 months of intervention
Secondary outcomes:
measure: Selenoprotein P in plasma
timeFrame: Measured at baseline
measure: Selenoprotein P in plasma
timeFrame: Measured after 3 months of intervention
measure: Selenoprotein P in plasma
timeFrame: Measured after 6 months of intervention
measure: Genetic polymorphisms in the selenoprotein P gene
timeFrame: Measured at baseline
measure: Genetic polymorphisms in the selenoprotein P gene
timeFrame: Measured after 3 months of intervention
measure: Genetic polymorphisms in the selenoprotein P gene
timeFrame: Measured after 6 months of intervention
measure: Heavy metals in whole blood (lead, cadmium, and mercury)
timeFrame: Measured at baseline
measure: Heavy metals in whole blood (lead, cadmium, and mercury)
timeFrame: Measured after 3 months of intervention
measure: Heavy metals in whole blood (lead, cadmium, and mercury)
timeFrame: Measured after 6 months of intervention
measure: Blood pressure
timeFrame: Measured at baseline
measure: Blood pressure
timeFrame: Measured after 3 months of intervention
measure: Blood pressure
timeFrame: Measured after 6 months of intervention
measure: Anthropometry (weight, height, waist, and hip circumference)
timeFrame: Measured at baseline
measure: Anthropometry (weight, height, waist, and hip circumference)
timeFrame: Measured after 3 months of intervention
measure: Anthropometry (weight, height, waist, and hip circumference)
timeFrame: Measured after 6 months of intervention
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Institute of Cancer Epidemiology, Danish Cancer Society
Study officials:
affiliation: Institute of Cancer Epidemiology, Danish Cancer Society
name: Anne Tjonneland, professor, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: