Iodine ToxicityNCT05940727
Macroalgae Consumption - a Pilot Study
A study testing Habitual macroalgae consumption and No macroalgae consumption in people with Iodine Toxicity, run by University of Bergen at 1 site in Norway.
Trial summary
In this study, the aim is to investigate the food safety of macroalgae. There will be an analysis of macroalgae products for the concentration of cadmium, inorganic arsenic, and iodine in macroalgae, as well as measure the status of these elements in consumers. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Iodine Toxicity
- What is being tested?
- Habitual macroalgae consumption and No macroalgae consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2022to 1 Jan 2023
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults
- weekly consumer of macroalgae
Who cannot join
- pregnant
- known disease
Trial locations and contacts
1 site in 1 country.
About this study
In this study, the aim is to investigate the food safety of macroalgae. There will be an analysis of macroalgae products for the concentration of cadmium, inorganic arsenic, and iodine in macroalgae, as well as measure the status of these elements in consumers. An investigation of the thyroid function of macroalgae consumers and the use of metabolomics to explore which biological changes occur when consuming seaweed and kelp and when the consumer excludes macroalgae from their diet will be performed.
Read the detailed description
A group of consumers of macroalgae will be recruited to investigate their macroalgae intake and iodine, cadmium, and inorganic arsenic status and thyroid function. Iodine, cadmium, and inorganic arsenic have been selected since these elements have been described as relatively high in a previously published report from Norway. The goal is to recruit consumers of brown algae - especially kelp, and certain types of red algae, as these were the species with the highest content of iodine, cadmium, and arsenic, described in a previous publication. The participants will be asked to abstain from macroalgae for 6 weeks and again examine iodine status, cadmium and arsenic exposure, and thyroid function after the cessation period. A withdrawal period of 6 weeks has been chosen on the basis that it is calculated 6-8 weeks after Levaxin treatment for hypothyroidism before a new equilibrium can be expected and the effect of treatment on TSH can be assessed.
This study will provide new insight into the status of iodine, cadmium, and inorganic arsenic that macroalgae consumers have in urine and thyroid function after regular macroalgae consumption and after cessation of macroalgae intake. In addition, the study will provide descriptive data on macroalgae consumption, how it is eaten, how often, and how much. This can provide critical knowledge to the national and European authorities for food safety and public health advisers to evaluate the food safety of macroalgae.
- Conditions
- Iodine Toxicity
- Being tested
- Habitual macroalgae consumption, No macroalgae consumption
- Keywords
- macroalgae, iodine, consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Habitual macroalgae consumptionOther
The participant have a habitual macroalgae consumption at baseline.
No macroalgae consumptionOther
The participants exclude any macroalgae products from their diet
| Study group | Role | What they receive |
|---|---|---|
| Usual macroalgae consumption | Active comparator | Crossover design with habitual macroalgae consumption at baseline Receives: Other: Habitual macroalgae consumption; Other: No macroalgae consumption |
| Cessation of macroalgae consumption | Experimental | Cessation of macroalgae consumption as an experimental intervention. Receives: Other: Habitual macroalgae consumption; Other: No macroalgae consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of macroalgae products
Assess the dietary consumption of macroalgae in consumers in the Bergen and Oslo area by 24hr recall and food frequency questionnaire
Measured: Through study completion, on average 6 weeks
Levels of iodine, cadmium and inorganic arsenic in macroalgae products
Analyse the levels of iodine, cadmium and inorganic arsenic in macroalgae products used by the participants
Measured: Through study completion, on average 6 weeks
Secondary outcomes (11)
Levels of iodine
Analyse the levels of iodine in urine after intervention/usual macroalgae consumption
Measured: 6 weeks
Levels of cadmium in urine
Analyse the levels of cadmium urine after intervention/usual macroalgae consumption
Measured: 6 weeks
Levels of inorganic arsenic in urine
Analyse the levels of inorganic arsenic in urine after intervention/usual macroalgae consumption
Measured: 6 weeks
Levels of creatinine in urine
Analyse the of creatinine in urine after intervention/usual macroalgae consumption
Measured: 6 weeks
Thyroid function measure by thyroid-stimulating hormon
Measurement of thyroid-stimulating hormon (TSH) in serum after intervention/usual macroalgae consumption
Measured: 6 weeks
Thyroid function measure by ree-triiodinetyronin
Measurement of free-triiodinetyronin (fT3) in serum after intervention/usual macroalgae consumption
Measured: 6 weeks
Thyroid function measure by free thyroxine
Measurement of free thyroxine (fT4) in serum after intervention/usual macroalgae consumption
Measured: 6 weeks
Thyroid function measure by Thyroid peroxidase antibody
Measurement of Thyroid peroxidase antibody (TPOAb) in serum after intervention/usual macroalgae consumption
Measured: 6 weeks
Thyroid function measured by thyroglobulin
Measurement of thyroglobulin (Tg) in serum after intervention/usual macroalgae consumption
Measured: 6 weeks
Thyroid function
Measurement of thyroid-stimulating hormon (TSH), free-triiodinetyronin (fT3), free thyroxine (fT4), Thyroid peroxidase antibody (TPOAb), thyroglobulin (Tg) in serum after intervention/usual macroalgae consumption
Measured: 6 weeks
Metabolic changes
Measurement of metabolic changes by non-targeted metabolomics after intervention/usual macroalage consumption
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Jan 2022
- Primary completion15 Dec 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iodine ToxicityStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Marine Research
- Responsible party
- Sponsor
- Investigators
- Inger Aakre, PhD, Principal investigator, Institute of Marine Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940727
- Sponsor's protocol ID
- 332865
- Status last verified
- Jul 2023
- First submitted
- 6 Mar 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macroalgae Consumption - a Pilot Study
- ClinicalTrials.gov ID
- NCT05940727
- Acronym / sponsor ID
- 332865
- Conditions
- Iodine Toxicity
- Keywords
- macroalgae, iodine, consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Institute of Marine Research
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 11 Jul 2023 (actual)
- 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.
In this study, the aim is to investigate the food safety of macroalgae. There will be an analysis of macroalgae products for the concentration of cadmium, inorganic arsenic, and iodine in macroalgae, as well as measure the status of these elements in consumers. An investigation of the thyroid function of macroalgae consumers and the use of metabolomics to explore which biological changes occur when consuming seaweed and kelp and when the consumer excludes macroalgae from their diet will be performed.
Detailed description
A group of consumers of macroalgae will be recruited to investigate their macroalgae intake and iodine, cadmium, and inorganic arsenic status and thyroid function. Iodine, cadmium, and inorganic arsenic have been selected since these elements have been described as relatively high in a previously published report from Norway. The goal is to recruit consumers of brown algae - especially kelp, and certain types of red algae, as these were the species with the highest content of iodine, cadmium, and arsenic, described in a previous publication. The participants will be asked to abstain from macroalgae for 6 weeks and again examine iodine status, cadmium and arsenic exposure, and thyroid function after the cessation period. A withdrawal period of 6 weeks has been chosen on the basis that it is calculated 6-8 weeks after Levaxin treatment for hypothyroidism before a new equilibrium can be expected and the effect of treatment on TSH can be assessed.
This study will provide new insight into the status of iodine, cadmium, and inorganic arsenic that macroalgae consumers have in urine and thyroid function after regular macroalgae consumption and after cessation of macroalgae intake. In addition, the study will provide descriptive data on macroalgae consumption, how it is eaten, how often, and how much. This can provide critical knowledge to the national and European authorities for food safety and public health advisers to evaluate the food safety of macroalgae.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual macroalgae consumption | Active comparator | Other: Habitual macroalgae consumption, Other: No macroalgae consumptionCrossover design with habitual macroalgae consumption at baseline |
| Cessation of macroalgae consumption | Experimental | Other: Habitual macroalgae consumption, Other: No macroalgae consumptionCessation of macroalgae consumption as an experimental intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adults
- weekly consumer of macroalgae
Key exclusion criteria (2 listed)
- pregnant
- known disease
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 |
|---|---|---|
| Habitual macroalgae consumptionThe participant have a habitual macroalgae consumption at baseline. | Other | Cessation of macroalgae consumption, Usual macroalgae consumption |
| No macroalgae consumptionThe participants exclude any macroalgae products from their diet | Other | Cessation of macroalgae consumption, Usual macroalgae consumption |
Primary outcome
Consumption of macroalgae products
Time frame: Through study completion, on average 6 weeks
Assess the dietary consumption of macroalgae in consumers in the Bergen and Oslo area by 24hr recall and food frequency questionnaire
Levels of iodine, cadmium and inorganic arsenic in macroalgae products
Time frame: Through study completion, on average 6 weeks
Analyse the levels of iodine, cadmium and inorganic arsenic in macroalgae products used by the participants
11 secondary outcomes
Levels of iodine
Time frame: 6 weeks
Levels of cadmium in urine
Time frame: 6 weeks
Levels of inorganic arsenic in urine
Time frame: 6 weeks
Levels of creatinine in urine
Time frame: 6 weeks
Thyroid function measure by thyroid-stimulating hormon
Time frame: 6 weeks
Thyroid function measure by ree-triiodinetyronin
Time frame: 6 weeks
Thyroid function measure by free thyroxine
Time frame: 6 weeks
Thyroid function measure by Thyroid peroxidase antibody
Time frame: 6 weeks
Thyroid function measured by thyroglobulin
Time frame: 6 weeks
Thyroid function
Time frame: 6 weeks
Metabolic changes
Time frame: 6 weeks
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 11 Jul 2023.
- Individual participant dataSharing planned: No
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.
Inger Aakre, PhD principal investigator
Institute of Marine Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Habitual macroalgae consumption and No macroalgae consumption in people with Iodine Toxicity, run by University of Bergen at 1 site in Norway.
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 2 inclusion and 2 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 11 Jul 2023. 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 Norway. 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.
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?
Consumption of macroalgae products (time frame: Through study completion, on average 6 weeks). The study lists 2 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 11 Jul 2023; AzTrials last refreshed its copy on 31 Oct 2026.