NCT04867031

Brief Summary

This study is a randomized crossover trial, lasting 12 days in total, which will assess the difference in iodine bioavailability (as a percentage of iodine consumed that is excreted in urine) from three iodine-rich foods; semi-skimmed milk, white fish, and dried seaweed sheets. Each of the three foods will provide approximately 140µg of iodine, and iodine excretion will be monitored for 36 hours following food ingestion via collection and analysis of urine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

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 26, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2018

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

10 months

First QC Date

April 27, 2021

Last Update Submit

January 6, 2023

Conditions

Iodine Bioavailability

Keywords

iodinebioavailabilityseaweedmilkfish

Outcome Measures

Primary Outcomes (1)

  • Iodine concentration in urine (µg/L)

    Measured using the Sandell-Kolthoff method

    36 hours (fractions: 1-2, 2-3, 3-5, 5-7, 7-12, 12-24, 24-36 hours)

Study Arms (3)

White fish (cod)

EXPERIMENTAL

Participants will consume 1 portion (\~130g) of white fish (Bird's Eye Inspirations Cod Fillets with Tomato \& Rosemary), providing approximately 140µg of iodine, alongside 452mL of water. Urine will be collected for 36 hours following test food consumption.

Dietary Supplement: Fish

Semi-skimmed milk

EXPERIMENTAL

Participants will consume 1 portion (\~450mL) of milk (Tesco UHT Semi-Skimmed), providing approximately 140µg of iodine, alongside 452mL of water. Urine will be collected for 36 hours following test food consumption.

Dietary Supplement: Milk

Dried seaweed sheets

EXPERIMENTAL

Participants will consume 1 portion (\~6g) of dried seaweed sheets (Itsu Crispy Seaweed Thins), providing approximately 140µg of iodine, alongside 452mL of water. Urine will be collected for 36 hours following test food consumption.

Dietary Supplement: Seaweed

Interventions

MilkDIETARY_SUPPLEMENT

One portion of semi-skimmed cow's milk (approx. 450mL), providing \~140µg of iodine.

Semi-skimmed milk
FishDIETARY_SUPPLEMENT

One portion of cod (approx. 130g), providing \~140µg of iodine.

White fish (cod)
SeaweedDIETARY_SUPPLEMENT

One portion of dried seaweed sheets (approx. 6g), providing \~140µg of iodine.

Dried seaweed sheets

Eligibility Criteria

Age18 Years - 48 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Male or female
  • Aged 18-48
  • Signed informed consent

You may not qualify if:

  • Pregnancy and lactation
  • Past and present thyroid conditions
  • Diseases of the gastrointestinal tract
  • Allergy to seafood or dairy
  • Consumption of iodine supplements
  • Currently taking medication (other than the contraceptive pill)
  • Having a habitual diet very low in iodine (\<1 portion of dairy per day, or \< 1 portion of fish per week)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Section of Human Nutrition, University of Glasgow

Glasgow, North Lanarkshire, G31 2ER, United Kingdom

Location

MeSH Terms

Interventions

MilkIn Situ Hybridization, Fluorescence

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and BeveragesIn Situ HybridizationStaining and LabelingHistocytological Preparation TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesCytogenetic AnalysisGenetic TechniquesNucleic Acid Hybridization

Study Officials

  • Emilie Combet, PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer in Nutrition

Study Record Dates

First Submitted

April 27, 2021

First Posted

April 30, 2021

Study Start

August 26, 2017

Primary Completion

July 3, 2018

Study Completion

July 3, 2018

Last Updated

January 10, 2023

Record last verified: 2023-01

Locations

GB(1)