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

Study Overview
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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.

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

Conditions
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Selenium Status, Selenium Uptake From Fish and Shellfish

Intervention / Treatment
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* Dietary Supplement: Fish and shellfish


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fish and shellfish<br> | Dietary Supplement: Fish and shellfish<br>* Intake of 1000 grams of fish and shellfish per week for six months.<br>|
| No Intervention: Control<br>Assessment only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Selenium concentration in whole blood |  | Measured at baseline | 
| Selenium concentration in whole blood |  | Measured after 3 months of intervention | 
| Selenium concentration in whole blood |  | Measured after 6 months of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Selenoprotein P in plasma |  | Measured at baseline | 
| Selenoprotein P in plasma |  | Measured after 3 months of intervention | 
| Selenoprotein P in plasma |  | Measured after 6 months of intervention | 
| Genetic polymorphisms in the selenoprotein P gene |  | Measured at baseline | 
| Genetic polymorphisms in the selenoprotein P gene |  | Measured after 3 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 at baseline | 
| Heavy metals in whole blood (lead, cadmium, and mercury) |  | Measured after 3 months of intervention | 
| Heavy metals in whole blood (lead, cadmium, and mercury) |  | Measured after 6 months of intervention | 
| Blood pressure |  | Measured at baseline | 
| Blood pressure |  | Measured after 3 months of intervention | 
| Blood pressure |  | Measured after 6 months of intervention | 
| Anthropometry (weight, height, waist, and hip circumference) |  | Measured at baseline | 
| Anthropometry (weight, height, waist, and hip circumference) |  | Measured after 3 months of intervention | 
| Anthropometry (weight, height, waist, and hip circumference) |  | Measured after 6 months of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Selenium, Selenoprotein P, Fish, Shellfish, Bioavailability