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

Selenium Status Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224249
• Other study ID #: DCS-53227244
• Status: Completed
• Phase: Phase 1
• First received: October 18, 2010
• Last updated: September 28, 2011
• Start date: August 2010
• Est. completion date: March 2011

Study information

• Verified date: August 2011
• Source: Danish Cancer Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 74 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Selenium Status
• Selenium Uptake From Fish and Shellfish

Intervention

Dietary Supplement:
• Fish and shellfish
Intake of 1000 grams of fish and shellfish per week for six months.

Locations

Country	Name	City	State
Denmark	Institute of Cancer Epidemiology, Danish Cancer Society	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Danish Cancer Society	Danish Shellfish Center, Technical University of Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Selenium concentration in whole blood		Measured at baseline	No
Primary	Selenium concentration in whole blood		Measured after 3 months of intervention	No
Primary	Selenium concentration in whole blood		Measured after 6 months of intervention	No
Secondary	Selenoprotein P in plasma		Measured at baseline	No
Secondary	Selenoprotein P in plasma		Measured after 3 months of intervention	No
Secondary	Selenoprotein P in plasma		Measured after 6 months of intervention	No
Secondary	Genetic polymorphisms in the selenoprotein P gene		Measured at baseline	No
Secondary	Genetic polymorphisms in the selenoprotein P gene		Measured after 3 months of intervention	No
Secondary	Genetic polymorphisms in the selenoprotein P gene		Measured after 6 months of intervention	No
Secondary	Heavy metals in whole blood (lead, cadmium, and mercury)		Measured at baseline	No
Secondary	Heavy metals in whole blood (lead, cadmium, and mercury)		Measured after 3 months of intervention	No
Secondary	Heavy metals in whole blood (lead, cadmium, and mercury)		Measured after 6 months of intervention	No
Secondary	Blood pressure		Measured at baseline	No
Secondary	Blood pressure		Measured after 3 months of intervention	No
Secondary	Blood pressure		Measured after 6 months of intervention	No
Secondary	Anthropometry (weight, height, waist, and hip circumference)		Measured at baseline	No
Secondary	Anthropometry (weight, height, waist, and hip circumference)		Measured after 3 months of intervention	No
Secondary	Anthropometry (weight, height, waist, and hip circumference)		Measured after 6 months of intervention	No