NCT04867291

Brief Summary

This study explores the influence of the food matrix of seaweed-containing food products on iodine bioavailability. The investigation will ascertain whether iodine bioavailability (as a percentage of the dose ingested that is excreted in urine) is comparable between seaweed sheets, seaweed powder (in capsules), pizza fortified with powdered seaweed, and potassium iodide supplements.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
26 days 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
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

7 months

First QC Date

April 27, 2021

Last Update Submit

April 29, 2021

Conditions

Iodine Bioavailability

Outcome Measures

Primary Outcomes (1)

  • Urinary Iodine Excretion (micrograms/L)

    The percentage of iodine ingested from the test foods that is excreted in the 36 hours following test food ingestion will be measured in urine collected fractions: 1-2, 2-3, 3-5, 5-7, 7-12, 12-24, 24-36 hours

    36 hours

Secondary Outcomes (1)

  • Fecal Iodine Excretion (micrograms/g feces)

    24 hours

Other Outcomes (2)

  • Gut Bacterial Diversity

    Prior to commencement of trial

  • Seaweed Fermentation Capacity

    Prior to commencement of trial

Study Arms (4)

Pizza

EXPERIMENTAL

Consumption of a portion of Eat Balanced pizza equivalent to 200 µg of iodine (half a pizza) consumed with 450 mL water. Collection of urine for 36 hours following pizza ingestion. Collection of one fecal sample up to 24 hours following pizza ingestion.

Dietary Supplement: Pizza

Seaweed Sheets

EXPERIMENTAL

Consumption of a portion of Itsu Crispy Seaweed Thins equivalent to 200 µg of iodine (10g) consumed with 450 mL water. Collection of urine for 36 hours following ingestion. Collection of one fecal sample up to 24 hours following ingestion.

Dietary Supplement: Seaweed Sheets

Seaweed Powder

EXPERIMENTAL

Consumption of a portion of seaweed powder in a capsule equivalent to 200 µg of iodine (0.25g) consumed with 450 mL water. Collection of urine for 36 hours following ingestion. Collection of one fecal sample up to 24 hours following ingestion.

Dietary Supplement: Seaweed Powder

Potassium Iodide Supplement

EXPERIMENTAL

Consumption of a portion of Piping Rock Potassium Iodide supplements equivalent to 200 µg of iodine (1.3 tablets) consumed with 450 mL water. Collection of urine for 36 hours following ingestion. Collection of one fecal sample up to 24 hours following ingestion.

Dietary Supplement: Potassium iodide

Interventions

PizzaDIETARY_SUPPLEMENT

Portion equivalent to 200 µg of iodine (half a pizza), consumed with \~450mL of water.

Pizza
Seaweed SheetsDIETARY_SUPPLEMENT

Portion equivalent to 200 µg of iodine (\~10g), consumed with two slices of white bread and \~450mL of water.

Seaweed Sheets
Seaweed PowderDIETARY_SUPPLEMENT

Portion equivalent to 200 µg of iodine (1 capsule), consumed with two slices of white bread and \~450mL of water.

Seaweed Powder
Potassium iodideDIETARY_SUPPLEMENT

Portion equivalent to 200 µg of iodine (1.3 tablets), consumed with two slices of white bread and \~450mL of water.

Potassium Iodide Supplement

Eligibility Criteria

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

You may qualify if:

  • Healthy
  • Premenopausal women
  • years old
  • Signed informed consent

You may not qualify if:

  • Pregnancy and lactation
  • Past and present thyroid conditions/dysfunction
  • Allergy to gluten, wheat, or dairy
  • Iodine supplement consumption
  • Currently taking medication (other than contraceptive)
  • Diseases of the gastrointestinal tract
  • Current smoker
  • Current vegan (pizza contains dairy cheese)
  • Having a habitual diet very low in iodine (\<1 portion of dairy per day, or \<1 portion of fish per week)
  • Having a habitual diet very high in iodine (\>4 portions of dairy per day, or \>4 portions of fish per week)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

PIZZA protein, ArabidopsisPotassium Iodide

Intervention Hierarchy (Ancestors)

IodidesIodine CompoundsInorganic ChemicalsPotassium Compounds

Study Officials

  • Emilie Combet, PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martha L Redway, BSc

CONTACT

07510924724m.redway.1@research.gla.ac.uk

Emilie Combet, PhD

CONTACT

0141 201 8527emilie.combetaspray@glasgow.ac.uk

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

April 1, 2021

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

April 30, 2021

Record last verified: 2021-04