Iodine BioavailabilityIoBioNCT04867291
Seaweed, the Food Matrix, and Iodine Bioavailability
A study testing Pizza, Seaweed Sheets and Seaweed Powder in people with Iodine Bioavailability, run by University of Glasgow.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iodine Bioavailability
- What is being tested?
- Pizza, Seaweed Sheets and Seaweed Powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Premenopausal women
- 18-48 years old
- Signed informed consent
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Food arm: portion equivalent to 200µg of iodine, half a pizza (Eat Balanced pizza) (consumed with ~450mL of water)
- Seaweed sheet arm: portion equivalent to 200µg of iodine, ~10g of seaweed sheets (consumed alongside 2 slices of white bread and ~450mL of water)
- Seaweed powder arm: portion equivalent to 200µg of iodine, 1 capsule (consumed alongside 2 slices of white bread and ~450mL of water).
- 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
- Iodine Bioavailability
- Being tested
- Pizza, Seaweed Sheets, Seaweed Powder, Potassium iodide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PizzaDietary supplement
Portion equivalent to 200 µg of iodine (half a pizza), consumed with ~450mL of water.
Seaweed SheetsDietary supplement
Portion equivalent to 200 µg of iodine (~10g), consumed with two slices of white bread and ~450mL of water.
Seaweed PowderDietary supplement
Portion equivalent to 200 µg of iodine (1 capsule), consumed with two slices of white bread and ~450mL of water.
Potassium iodideDietary supplement
Portion equivalent to 200 µg of iodine (1.3 tablets), consumed with two slices of white bread and ~450mL of water.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Potassium iodide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 36 hours
Secondary outcomes (1)
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study startApr 2021 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iodine BioavailabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilie Combet, University of Glasgow
- Investigators
- Emilie Combet, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867291
- Sponsor's protocol ID
- 200180075
- Acronym
- IoBio
- Status last verified
- Apr 2021
- First submitted
- 27 Apr 2021
- Last updated
- 30 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seaweed, the Food Matrix, and Iodine Bioavailability
- ClinicalTrials.gov ID
- NCT04867291
- Acronym / sponsor ID
- IoBio / 200180075
- Conditions
- Iodine Bioavailability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
- Food arm: portion equivalent to 200µg of iodine, half a pizza (Eat Balanced pizza) (consumed with ~450mL of water)
- Seaweed sheet arm: portion equivalent to 200µg of iodine, ~10g of seaweed sheets (consumed alongside 2 slices of white bread and ~450mL of water)
- Seaweed powder arm: portion equivalent to 200µg of iodine, 1 capsule (consumed alongside 2 slices of white bread and ~450mL of water).
- 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pizza | Experimental | Dietary Supplement: PizzaConsumption 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. |
| Seaweed Sheets | Experimental | Dietary Supplement: Seaweed SheetsConsumption 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. |
| Seaweed Powder | Experimental | Dietary Supplement: Seaweed PowderConsumption 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. |
| Potassium Iodide Supplement | Experimental | Dietary Supplement: Potassium iodideConsumption 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. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy
- Premenopausal women
- 18-48 years old
- Signed informed consent
Key exclusion criteria (10 listed)
- Pregnancy and lactation
- Past and present thyroid conditions/dysfunction
- Allergy to gluten, wheat, or dairy
- Iodine supplement consumption
- Currently taking medication (other than contraceptive)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PizzaPortion equivalent to 200 µg of iodine (half a pizza), consumed with ~450mL of water. | Dietary supplement | Pizza |
| Seaweed SheetsPortion equivalent to 200 µg of iodine (~10g), consumed with two slices of white bread and ~450mL of water. | Dietary supplement | Seaweed Sheets |
| Seaweed PowderPortion equivalent to 200 µg of iodine (1 capsule), consumed with two slices of white bread and ~450mL of water. | Dietary supplement | Seaweed Powder |
| Potassium iodidePortion equivalent to 200 µg of iodine (1.3 tablets), consumed with two slices of white bread and ~450mL of water. | Dietary supplement | Potassium Iodide Supplement |
Primary outcome
Urinary Iodine Excretion (micrograms/L)
Time frame: 36 hours
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
1 secondary outcome
Fecal Iodine Excretion (micrograms/g feces)
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Iodine Bioavailability
Not yet recruiting
Bioavailability of Micronutrients With a Special Focus on Vitamin K Dependent on Consumed Diet
Micronutrient Status
Active, not recruiting
The Bioavailability of Iodine in Plant-based Milk Alternatives
Iodine Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie Combet, PhD principal investigator
University of Glasgow
Questions about this trial
What is this clinical trial studying?
A study testing Pizza, Seaweed Sheets and Seaweed Powder in people with Iodine Bioavailability, run by University of Glasgow.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martha L Redway, BSc (07510924724, m.redway.1@research.gla.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Iodine Excretion (micrograms/L) (time frame: 36 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.