- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05773456
Iodine Status After Intake of Sushi and Seaweed Salad
April 11, 2023 updated by: University of Bergen
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bergen, Norway, 5021
- University of Bergen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- healthy women aged 18 to 40 years
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sushi and wakame salad
231 microgram of iodine per serving
|
One serving of mixed sushi and wakame salad
|
|
Active Comparator: Potassium iodide supplement
225 microgram of iodine per tablet
|
One serving of mixed sushi and wakame salad
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
48 hours
|
|
Bio-availability of iodine in the intervention/supplement
Time Frame: 48 hours
|
Calculation of the bio-availability of iodine in the intervention/supplement
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Inger Aakre, PhD, Institute of Marine Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 10, 2021
Primary Completion (Actual)
January 1, 2022
Study Completion (Actual)
June 15, 2022
Study Registration Dates
First Submitted
March 6, 2023
First Submitted That Met QC Criteria
March 6, 2023
First Posted (Actual)
March 17, 2023
Study Record Updates
Last Update Posted (Actual)
April 12, 2023
Last Update Submitted That Met QC Criteria
April 11, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 232247
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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