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

D

Danish Cancer Society

Status and phase

Completed
Phase 1

Conditions

Selenium Status
Selenium Uptake From Fish and Shellfish

Treatments

Dietary Supplement: Fish and shellfish

Study type

Interventional

Funder types

Other

Identifiers

NCT01224249
DCS-53227244

Details and patient eligibility

About

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.

Full 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.

Enrollment

102 patients

Sex

All

Ages

50 to 74 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

102 participants in 2 patient groups

Fish and shellfish
Active Comparator group
Treatment:
Dietary Supplement: Fish and shellfish
Control
No Intervention group
Description:
Assessment only

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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