Iodine DeficiencyNCT05773456
Iodine Status After Intake of Sushi and Seaweed Salad
A study testing Sushi and wakame salad in people with Iodine Deficiency, run by University of Bergen at 1 site in Norway.
Trial summary
Seaweed is becoming increasingly popular in the Western part of the world, especially sushi wrapped in nori and seaweed salad, also called wakame. There are limited data on the iodine content of different seaweed products in the Norwegian Food composition table. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iodine Deficiency
- What is being tested?
- Sushi and wakame salad
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteNorway
- Study dates
- 10 Aug 2021to 15 Jun 2022
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy women aged 18 to 40 years
Who cannot join
- pregnant or lactating
- known thyroid disease or thyroid autoimmunity,
- planning to conceive,
- known kidney problems or kidney disease.
- women with coeliac disease could not participate due to possible gluten exposure from the wakame salad
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Iodine Status at Several Time Points During 48 Hours After Intake of Sushi and Seaweed Salad- a Randomized Crossover Trial
Seaweed is becoming increasingly popular in the Western part of the world, especially sushi wrapped in nori and seaweed salad, also called wakame. There are limited data on the iodine content of different seaweed products in the Norwegian Food composition table. Furthermore, there is limited available research regarding in vivo bioavailability of iodine from seaweeds. The objective of this study is to assess whether iodine from a sushi meal (with nori, Porphyra spp), and a wakame salad (Undaria pinnatifida) has similar bioavailability as a potassium iodide reference supplement of similar iodine content.
- Conditions
- Iodine Deficiency
- Being tested
- Sushi and wakame salad
- Keywords
- seaweed, bioavailability, iodine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sushi and wakame saladOther
One serving of mixed sushi and wakame salad
| Study group | Role | What they receive |
|---|---|---|
| Sushi and wakame salad | Experimental | 231 microgram of iodine per serving Receives: Other: Sushi and wakame salad |
| Potassium iodide supplement | Active comparator | 225 microgram of iodine per tablet Receives: Other: Sushi and wakame salad |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary iodine concentration during 48 hours
Urinary iodine concentration after ingestion of the intervention/supplement during 48 hours by fixed time-intervals
Measured: 48 hours
Bio-availability of iodine in the intervention/supplement
Calculation of the bio-availability of iodine in the intervention/supplement
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start10 Aug 2021
- Primary completion1 Jan 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iodine DeficiencyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT05773456
- Sponsor's protocol ID
- 232247
- Status last verified
- Jan 2023
- First submitted
- 6 Mar 2023
- Last updated
- 12 Apr 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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iodine Status at Several Time Points During 48 Hours After Intake of Sushi and Seaweed Salad- a Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT05773456
- Acronym / sponsor ID
- 232247
- Conditions
- Iodine Deficiency
- Keywords
- seaweed, bioavailability, iodine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Institute of Marine Research
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 17 Mar 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.
Seaweed is becoming increasingly popular in the Western part of the world, especially sushi wrapped in nori and seaweed salad, also called wakame. There are limited data on the iodine content of different seaweed products in the Norwegian Food composition table. Furthermore, there is limited available research regarding in vivo bioavailability of iodine from seaweeds. The objective of this study is to assess whether iodine from a sushi meal (with nori, Porphyra spp), and a wakame salad (Undaria pinnatifida) has similar bioavailability as a potassium iodide reference supplement of similar iodine content.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sushi and wakame salad | Experimental | Other: Sushi and wakame salad231 microgram of iodine per serving |
| Potassium iodide supplement | Active comparator | Other: Sushi and wakame salad225 microgram of iodine per tablet |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy women aged 18 to 40 years
Key exclusion criteria (5 listed)
- pregnant or lactating
- known thyroid disease or thyroid autoimmunity,
- planning to conceive,
- known kidney problems or kidney disease.
- women with coeliac disease could not participate due to possible gluten exposure from the wakame salad
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 |
|---|---|---|
| Sushi and wakame saladOne serving of mixed sushi and wakame salad | Other | Potassium iodide supplement, Sushi and wakame salad |
Primary outcome
Urinary iodine concentration during 48 hours
Time frame: 48 hours
Urinary iodine concentration after ingestion of the intervention/supplement during 48 hours by fixed time-intervals
Bio-availability of iodine in the intervention/supplement
Time frame: 48 hours
Calculation of the bio-availability of iodine in the intervention/supplement
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 12 Apr 2023.
- Individual participant dataSharing planned: No
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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 Sushi and wakame salad in people with Iodine Deficiency, 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 1 inclusion and 5 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 12 Apr 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?
Urinary iodine concentration during 48 hours (time frame: 48 hours). 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 12 Apr 2023.