NCT05773456

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 17, 2023

Completed
Last Updated

April 12, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

March 6, 2023

Last Update Submit

April 11, 2023

Conditions

Iodine Deficiency

Keywords

seaweedbioavailabilityiodine

Outcome Measures

Primary Outcomes (2)

  • Urinary iodine concentration during 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

    Calculation of the bio-availability of iodine in the intervention/supplement

    48 hours

Study Arms (2)

Sushi and wakame salad

EXPERIMENTAL

231 microgram of iodine per serving

Other: Sushi and wakame salad

Potassium iodide supplement

ACTIVE COMPARATOR

225 microgram of iodine per tablet

Other: Sushi and wakame salad

Interventions

Sushi and wakame saladOTHER

One serving of mixed sushi and wakame salad

Potassium iodide supplementSushi and wakame salad

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy women aged 18 to 40 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bergen

Bergen, 5021, Norway

Location

Study Officials

  • Inger Aakre, PhD

    Institute of Marine Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2023

First Posted

March 17, 2023

Study Start

August 10, 2021

Primary Completion

January 1, 2022

Study Completion

June 15, 2022

Last Updated

April 12, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)