Selenium StatusPhase 1NCT01224249
Selenium Status Measured in Blood After a Higher Intake of Fish and Shellfish - a Randomized Dietary Intervention Study
A Phase 1 study testing Fish and shellfish in people with Selenium Status and Selenium Uptake From Fish and Shellfish, run by Danish Cancer Society at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Selenium Status, Selenium Uptake From Fish and Shellfish
- What is being tested?
- Fish and shellfish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2010to Mar 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men and women
- 50-74 years
- BMI 18.5-28 kg/m2
- non-smokers
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Cancer Epidemiology, Danish Cancer Society
Copenhagen, 2100
About this study
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.
Read the 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.
- Being tested
- Fish and shellfish
- Keywords
- Selenium, Selenoprotein P, Fish, Shellfish, Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish and shellfishDietary supplement
Intake of 1000 grams of fish and shellfish per week for six months.
| Study group | Role | What they receive |
|---|---|---|
| Fish and shellfish | Active comparator | Not described Receives: Dietary Supplement: Fish and shellfish |
| Control | No intervention | Assessment only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Selenium concentration in whole blood
Measured: Measured at baseline
Selenium concentration in whole blood
Measured: Measured after 3 months of intervention
Selenium concentration in whole blood
Measured: Measured after 6 months of intervention
Secondary outcomes (15)
Selenoprotein P in plasma
Measured: Measured at baseline
Selenoprotein P in plasma
Measured: Measured after 3 months of intervention
Selenoprotein P in plasma
Measured: Measured after 6 months of intervention
Genetic polymorphisms in the selenoprotein P gene
Measured: Measured at baseline
Genetic polymorphisms in the selenoprotein P gene
Measured: Measured after 3 months of intervention
Genetic polymorphisms in the selenoprotein P gene
Measured: Measured after 6 months of intervention
Heavy metals in whole blood (lead, cadmium, and mercury)
Measured: Measured at baseline
Heavy metals in whole blood (lead, cadmium, and mercury)
Measured: Measured after 3 months of intervention
Heavy metals in whole blood (lead, cadmium, and mercury)
Measured: Measured after 6 months of intervention
Blood pressure
Measured: Measured at baseline
Blood pressure
Measured: Measured after 3 months of intervention
Blood pressure
Measured: Measured after 6 months of intervention
Anthropometry (weight, height, waist, and hip circumference)
Measured: Measured at baseline
Anthropometry (weight, height, waist, and hip circumference)
Measured: Measured after 3 months of intervention
Anthropometry (weight, height, waist, and hip circumference)
Measured: Measured after 6 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Selenium StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Cancer Society
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Denmark, Danish Shellfish Center
- Investigators
- Anne Tjonneland, professor, M.D., Ph.D., Principal investigator, Institute of Cancer Epidemiology, Danish Cancer Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224249
- Sponsor's protocol ID
- DCS-53227244
- Status last verified
- Aug 2011
- First submitted
- 18 Oct 2010
- Last updated
- 29 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selenium Status Measured in Blood After a Higher Intake of Fish and Shellfish - a Randomized Dietary Intervention Study
- ClinicalTrials.gov ID
- NCT01224249
- Acronym / sponsor ID
- DCS-53227244
- Keywords
- Selenium, Selenoprotein P, Fish, Shellfish, Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Danish Cancer SocietyUniversity, hospital or other
- Collaborators
- Technical University of Denmark, Danish Shellfish Center
- Study start
- Aug 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 20 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish and shellfish | Active comparator | Dietary Supplement: Fish and shellfish |
| Control | No intervention | –Assessment only |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- men and women
- 50-74 years
- BMI 18.5-28 kg/m2
- non-smokers
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish and shellfishIntake of 1000 grams of fish and shellfish per week for six months. | Dietary supplement | Fish and shellfish |
Primary outcome
Selenium concentration in whole blood
Time frame: Measured at baseline
Selenium concentration in whole blood
Time frame: Measured after 3 months of intervention
Selenium concentration in whole blood
Time frame: Measured after 6 months of intervention
15 secondary outcomes
Selenoprotein P in plasma
Time frame: Measured at baseline
Selenoprotein P in plasma
Time frame: Measured after 3 months of intervention
Selenoprotein P in plasma
Time frame: Measured after 6 months of intervention
Genetic polymorphisms in the selenoprotein P gene
Time frame: Measured at baseline
Genetic polymorphisms in the selenoprotein P gene
Time frame: Measured after 3 months of intervention
Genetic polymorphisms in the selenoprotein P gene
Time frame: Measured after 6 months of intervention
Heavy metals in whole blood (lead, cadmium, and mercury)
Time frame: Measured at baseline
Heavy metals in whole blood (lead, cadmium, and mercury)
Time frame: Measured after 3 months of intervention
Heavy metals in whole blood (lead, cadmium, and mercury)
Time frame: Measured after 6 months of intervention
Blood pressure
Time frame: Measured at baseline
Blood pressure
Time frame: Measured after 3 months of intervention
Blood pressure
Time frame: Measured after 6 months of intervention
Anthropometry (weight, height, waist, and hip circumference)
Time frame: Measured at baseline
Anthropometry (weight, height, waist, and hip circumference)
Time frame: Measured after 3 months of intervention
Anthropometry (weight, height, waist, and hip circumference)
Time frame: Measured after 6 months of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Tjonneland, professor, M.D., Ph.D. principal investigator
Institute of Cancer Epidemiology, Danish Cancer Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fish and shellfish in people with Selenium Status and Selenium Uptake From Fish and Shellfish, run by Danish Cancer Society at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Selenium concentration in whole blood (time frame: Measured at baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2011.