Seaweed, the Food Matrix, and Iodine Bioavailability

NCT ID: NCT04867291

Last Updated: 2021-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-30

Study Completion Date

2021-11-30

Brief Summary

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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.

Detailed Description

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Iodine deficiency can have serious consequences, especially during pregnancy and lactation where the fetus is entirely dependent on its mother for the provision of iodine. There is no current iodine fortification programme in the United Kingdom, and the main sources of iodine are from dietary sources, such as dairy products and seafood. However, seaweed is also a rich source of iodine; the inclusion of iodine (via powdered seaweed) in commonly consumed foods is of potential benefit as a strategy, as it removes the need for consumers to alter their dietary behaviours, which are often culturally standardized.

Seaweed intake (via supplements) can increase the iodine status of women with habitually low-iodine diets. However, reduced bioavailability of iodine from the seaweed matrix has also been displayed, which could impact iodine intake should individuals choose to use seaweed as a dietary source of iodine.

This study tests the influence of the food matrix of seaweed-containing products on iodine bioavailability. This will be evaluated over the course of 27 days, in a randomized crossover trial design with 4 arms. Each arm will be separated by 7 washout days, and participants will follow a low iodine diet (avoiding all seafood, seaweed products, eggs, dairy, fortified plant milk and goitrogens (cabbage, soy etc.) for the 2 days preceding and the 1 day following each feed.

1. Food arm: portion equivalent to 200µg of iodine, half a pizza (Eat Balanced pizza) (consumed with \~450mL of water)
2. Seaweed sheet arm: portion equivalent to 200µg of iodine, \~10g of seaweed sheets (consumed alongside 2 slices of white bread and \~450mL of water)
3. Seaweed powder arm: portion equivalent to 200µg of iodine, 1 capsule (consumed alongside 2 slices of white bread and \~450mL of water).
4. Potassium iodide supplement arm: portion equivalent to 200µg of iodine with \~450mL of water (Piping Rock Potassium Iodide Supplement, consumed alongside 2 slices of white bread)

Iodine excretion will be monitored in urine collected during the 12 hours preceding and 36 hours following the meal. Urine will be collected in 8 timed fractions (0-1h, 1-2h, 2-3h, 3-5h, 5-8h, 8-12h, 12-24h, 24-36h) and participants will be provided with containers and instructions on how to collect their urine. A single fecal sample will also be collected before the first feed, and within 24 hours of all feeds. Participants will also keep a detailed food diary on all study days to enable iodine ingestion monitoring.

Conditions

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Iodine Bioavailability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Pizza

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.

Group Type EXPERIMENTAL

Pizza

Intervention Type DIETARY_SUPPLEMENT

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

Seaweed Sheets

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.

Group Type EXPERIMENTAL

Seaweed Sheets

Intervention Type DIETARY_SUPPLEMENT

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

Seaweed Powder

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.

Group Type EXPERIMENTAL

Seaweed Powder

Intervention Type DIETARY_SUPPLEMENT

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

Potassium Iodide Supplement

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.

Group Type EXPERIMENTAL

Potassium iodide

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Pizza

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

Intervention Type DIETARY_SUPPLEMENT

Seaweed Sheets

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

Intervention Type DIETARY_SUPPLEMENT

Seaweed Powder

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

Intervention Type DIETARY_SUPPLEMENT

Potassium iodide

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy
* Premenopausal women
* 18-48 years old
* Signed informed consent

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Glasgow

OTHER

Sponsor Role lead

Responsible Party

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Emilie Combet

Senior Lecturer in Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emilie Combet, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Central Contacts

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Martha L Redway, BSc

Role: CONTACT

Phone: 07510924724

Email: [email protected]

Emilie Combet, PhD

Role: CONTACT

Phone: 0141 201 8527

Email: [email protected]

Other Identifiers

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200180075

Identifier Type: -

Identifier Source: org_study_id