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

Phase 1

Completed

• Conditions: Selenium Status; Selenium Uptake From Fish and Shellfish
• Interventions: Dietary Supplement: Fish and shellfish

• Registration Number: NCT01224249
• Lead Sponsor: Danish Cancer Society

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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-10-18
• Study First Submitted QC: 2010-10-19
• Study First Posted: 2010-10-20
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-08
• Last Update Submitted: 2011-09-28
• Last Update Posted: 2011-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fish and shellfish	Fish and shellfish	-

Primary Outcome Measures

Name	Time	Method
Selenium concentration in whole blood	Measured after 6 months of intervention

Secondary Outcome Measures

Name	Time	Method
Selenoprotein P in plasma	Measured after 6 months of intervention
Genetic polymorphisms in the selenoprotein P gene	Measured after 6 months of intervention
Heavy metals in whole blood (lead, cadmium, and mercury)	Measured after 6 months of intervention
Blood pressure	Measured after 6 months of intervention
Anthropometry (weight, height, waist, and hip circumference)	Measured after 6 months of intervention

Trial Locations

Locations (1)

Institute of Cancer Epidemiology, Danish Cancer Society; 🇩🇰 Copenhagen, Denmark