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

NCT ID: NCT01224249

Last Updated: 2011-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-03-31

Brief Summary

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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

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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.

Conditions

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Selenium Status Selenium Uptake From Fish and Shellfish

Keywords

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Selenium Selenoprotein P Fish Shellfish Bioavailability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Fish and shellfish

Group Type ACTIVE_COMPARATOR

Fish and shellfish

Intervention Type DIETARY_SUPPLEMENT

Intake of 1000 grams of fish and shellfish per week for six months.

Control

Assessment only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fish and shellfish

Intake of 1000 grams of fish and shellfish per week for six months.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Technical University of Denmark

OTHER

Sponsor Role collaborator

Danish Shellfish Center

OTHER

Sponsor Role collaborator

Danish Cancer Society

OTHER

Sponsor Role lead

Responsible Party

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Institute of Cancer Epidemiology, Danish Cancer Society

Principal Investigators

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Anne Tjonneland, professor, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Institute of Cancer Epidemiology, Danish Cancer Society

Locations

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Institute of Cancer Epidemiology, Danish Cancer Society

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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DCS-53227244

Identifier Type: -

Identifier Source: org_study_id