Seaweed, the Food Matrix, and Iodine Bioavailability (IoBio)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Iodine Bioavailability
• Intervention / Treatment: Dietary supplement: Pizza; Dietary supplement: Seaweed Sheets; Dietary supplement: Seaweed Powder; Dietary supplement: Potassium iodide

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martha L Redway, BSc; Phone Number: 07510924724; Email: m.redway.1@research.gla.ac.uk
• Study Contact Backup: Name: Emilie Combet, PhD; Phone Number: 0141 201 8527; Email: emilie.combetaspray@glasgow.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Pizza; Portion equivalent to 200 µg of iodine (half a pizza), consumed with ~450mL of water.
Experimental: 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.	Dietary supplement: Seaweed Sheets; Portion equivalent to 200 µg of iodine (~10g), consumed with two slices of white bread and ~450mL of water.
Experimental: 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.	Dietary supplement: Seaweed Powder; Portion equivalent to 200 µg of iodine (1 capsule), consumed with two slices of white bread and ~450mL of water.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal Iodine Excretion (micrograms/g feces)	The percentage of iodine ingested from the test foods that is excreted in a single fecal sample passed in the 24 hours following test food ingestion	24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut Bacterial Diversity	Assessed via single fecal sample	Prior to commencement of trial
Seaweed Fermentation Capacity	Assessment of the capacity of participants' gut microflora to ferment seaweed polysaccharides and release iodine from the food matrix. Assessed via single fecal sample used in an in vitro fermentation model.	Prior to commencement of trial

Collaborators and Investigators

• Sponsor: University of Glasgow

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): April 30, 2021

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 200180075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No