Iodine DeficiencyINNOVATENCT04875377
Seaweed Iodine Delivered Via Food or Supplementation
A study testing Reformulated pizza and Seaweed capsule in people with Iodine Deficiency, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
In this project, the investigators propose an intervention design testing the efficacy of a food reformulated with seaweed as an ingredient in meal, capsules against placebo and no intervention controls. The randomised control trial (supplementation) will last 24 weeks. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iodine Deficiency
- What is being tested?
- Reformulated pizza and Seaweed capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Feb 2018to 5 Sep 2019
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- self-reported healthy women
- aged 18 to 60
- pre-menopausal
- with no history of thyroid dysfunction
- without any known allergic reactions to foods
- not on medication that impact on absorption of nutrients from the gut
- not currently taking dietary / multivitamin supplements (must have discontinued usage 2 weeks prior the start of the study)
Who cannot join
- pregnancy
- lactation
- habitual consumption of seaweed-based products (>once per week), milk (>once per day), sea fish, non-oily, e.g. cod (>once per week)
- veganism (as food products contains cheese)
- Involvement in another research study where diet is restricted, modified, or dietary habits are studied.
- women who have reached menopause.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Iodine From Seaweed - a Randomised Controlled Trial of Food Versus Supplementation in Women With Marginal Habitual Iodine Intake
In this project, the investigators propose an intervention design testing the efficacy of a food reformulated with seaweed as an ingredient in meal, capsules against placebo and no intervention controls. The randomised control trial (supplementation) will last 24 weeks. The aim is to study the effect of the food matrix on variables associated with iodine nutrition: iodine status and thyroid function.
Read the detailed description
This study is a randomized, double-blind, placebo-controlled trial conducted in Glasgow, United Kingdom. Inclusion criteria are as follows: healthy premenopausal women aged 18 - 60 years who would remain a resident in Glasgow for 24 weeks; who were self-reported low iodine consumers consuming milk less than once per day and non-oily fish less than once per week. Those with a history of thyroid dysfunction, taking medications other than the contraceptive pill or smoking, as well as pregnant or lactating women and those planning to conceive, were excluded. Those taking dietary supplements containing iodine would also excluded and there was no restriction related to body mass index (BMI).
Participants are recruited via social media and advertisements displayed around the Greater Glasgow area. Interested parties are screened and, if eligible, invited to a 30-minute appointment at which participants were randomly assigned through a web-based randomisation service to one of four groups after consent is obtained; reformulated pizza, control pizza, iodine capsules, or placebo capsules. During this initial meeting anthropometric measurements, blood pressure and a venous blood sample are collected, and participants are also asked to complete a sociodemographic questionnaire and an iodine specific food frequency questionnaire (FFQ). Participants are provided with instructions and equipment to record a 3-day estimated food diary and to collect 12 spot urine samples at different times of day over 2-7 days. Upon returning the spot urine samples, participants were given either the pizzas or supplements to begin the intervention. Participants are asked to consume one pizza or supplement three times a week for 24 weeks. Participants are asked to collect a further 10-12 sample spot urine samples at week 2 of the intervention. Participants are asked to attend another 30-minute appointment at 12 and 24 weeks in which baseline measurements are repeated along with a change to diet questionnaire.
- Conditions
- Iodine Deficiency
- Being tested
- Reformulated pizza, Control pizza, Seaweed capsule, Control capsule
- Keywords
- iodine, seaweed, supplementation, reformulation, food matrix, thyroid function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reformulated pizzaDietary supplement
Reformulated food with 400ug of iodine per meal, three times per week (to achieve 122% of weekly recommended intakes - average 140ug/day).
Control pizzaDietary supplement
Control (placebo) meal to consume thrice weekly (no iodine supplementation).
Seaweed capsuleDietary supplement
Capsules containing seaweed extract, the iodine-rich ingredient in the reformulated pizza, 400ug iodine per capsule, to be consumed three times per week (122% of weekly recommended intake).
Control capsuleDietary supplement
Empty capsules (placebo)
| Study group | Role | What they receive |
|---|---|---|
| Reformulated pizza | Experimental | Participants must consume a nutritionally balanced pizza reformulated with seaweed (Ascophyllum nodosum) as an ingredient 3 times a week for 24 weeks Receives: Dietary Supplement: Reformulated pizza |
| Control pizza | Placebo comparator | Participants must consume a nutritionally balanced pizza without seaweed, 3 times a week for 24 weeks Receives: Dietary Supplement: Control pizza |
| Seaweed capsule | Experimental | Participants must consume a capsule containing powdered Ascophyllum nodosum 3 times a week for 24 weeks Receives: Dietary Supplement: Seaweed capsule |
| Control capsule | Placebo comparator | Participants must consume an empty capsule 3 times a week for 24 weeks Receives: Dietary Supplement: Control capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urinary iodine concentration (UIC)
Change in UIC assessed in pooled spot urine samples at 12 weeks, from baseline
Measured: 0, 12 weeks
Change in urinary iodine concentration (UIC)
Change in UIC assessed in pooled spot urine samples at 24 weeks, from baseline
Measured: 0, 24 weeks
Secondary outcomes (9)
Changes in body weight
Changes in body weight assessed from baseline at 12 and 24 weeks
Measured: 0, 12, 24 weeks
Changes in body mass index
Changes in body mass index assessed from baseline at 12 and 24 weeks
Measured: 0, 12, 24 weeks
Changes in waist circumference
Changes in waist circumference assessed from baseline at 12 and 24 weeks
Measured: 0, 12, 24 weeks
Concentration of thyroid stimulating hormone
measured by immunoassay
Measured: 0, 12, 24 weeks
Concentration of thyroglobulin
measured by immunoassay
Measured: 0, 12, 24 weeks
Concentration of Free Triiodothyronine
measured by immunoassay
Measured: 0, 12, 24 weeks
Concentration of Thyroxine
measured by immunoassay
Measured: 0, 12, 24 weeks
Dietary iodine intake
estimated by food frequency questionnaire (FFQ)
Measured: 0, 12, 24 weeks
Change in urinary iodine concentration (UIC)
Change in UIC assessed in pooled spot urine samples at 2 weeks, from baseline
Measured: 0, 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start12 Feb 2018
- Primary completion5 Sep 2019
- Study completion5 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iodine DeficiencyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
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, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875377
- Sponsor's protocol ID
- 133109
- Acronym
- INNOVATE
- Status last verified
- Jan 2023
- First submitted
- 27 Apr 2021
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iodine From Seaweed - a Randomised Controlled Trial of Food Versus Supplementation in Women With Marginal Habitual Iodine Intake
- ClinicalTrials.gov ID
- NCT04875377
- Acronym / sponsor ID
- INNOVATE / 133109
- Conditions
- Iodine Deficiency
- Keywords
- iodine, seaweed, supplementation, reformulation, food matrix, thyroid function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 6 May 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.
In this project, the investigators propose an intervention design testing the efficacy of a food reformulated with seaweed as an ingredient in meal, capsules against placebo and no intervention controls. The randomised control trial (supplementation) will last 24 weeks. The aim is to study the effect of the food matrix on variables associated with iodine nutrition: iodine status and thyroid function.
Detailed description
This study is a randomized, double-blind, placebo-controlled trial conducted in Glasgow, United Kingdom. Inclusion criteria are as follows: healthy premenopausal women aged 18 - 60 years who would remain a resident in Glasgow for 24 weeks; who were self-reported low iodine consumers consuming milk less than once per day and non-oily fish less than once per week. Those with a history of thyroid dysfunction, taking medications other than the contraceptive pill or smoking, as well as pregnant or lactating women and those planning to conceive, were excluded. Those taking dietary supplements containing iodine would also excluded and there was no restriction related to body mass index (BMI).
Participants are recruited via social media and advertisements displayed around the Greater Glasgow area. Interested parties are screened and, if eligible, invited to a 30-minute appointment at which participants were randomly assigned through a web-based randomisation service to one of four groups after consent is obtained; reformulated pizza, control pizza, iodine capsules, or placebo capsules. During this initial meeting anthropometric measurements, blood pressure and a venous blood sample are collected, and participants are also asked to complete a sociodemographic questionnaire and an iodine specific food frequency questionnaire (FFQ). Participants are provided with instructions and equipment to record a 3-day estimated food diary and to collect 12 spot urine samples at different times of day over 2-7 days. Upon returning the spot urine samples, participants were given either the pizzas or supplements to begin the intervention. Participants are asked to consume one pizza or supplement three times a week for 24 weeks. Participants are asked to collect a further 10-12 sample spot urine samples at week 2 of the intervention. Participants are asked to attend another 30-minute appointment at 12 and 24 weeks in which baseline measurements are repeated along with a change to diet questionnaire.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Randomized, double-blind, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Reformulated pizza | Experimental | Dietary Supplement: Reformulated pizzaParticipants must consume a nutritionally balanced pizza reformulated with seaweed (Ascophyllum nodosum) as an ingredient 3 times a week for 24 weeks |
| Control pizza | Placebo comparator | Dietary Supplement: Control pizzaParticipants must consume a nutritionally balanced pizza without seaweed, 3 times a week for 24 weeks |
| Seaweed capsule | Experimental | Dietary Supplement: Seaweed capsuleParticipants must consume a capsule containing powdered Ascophyllum nodosum 3 times a week for 24 weeks |
| Control capsule | Placebo comparator | Dietary Supplement: Control capsuleParticipants must consume an empty capsule 3 times a week for 24 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- self-reported healthy women
- aged 18 to 60
- pre-menopausal
- with no history of thyroid dysfunction
- without any known allergic reactions to foods
Key exclusion criteria (6 listed)
- pregnancy
- lactation
- habitual consumption of seaweed-based products (>once per week), milk (>once per day), sea fish, non-oily, e.g. cod (>once per week)
- veganism (as food products contains cheese)
- Involvement in another research study where diet is restricted, modified, or dietary habits are studied.
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 |
|---|---|---|
| Reformulated pizzaReformulated food with 400ug of iodine per meal, three times per week (to achieve 122% of weekly recommended intakes - average 140ug/day). | Dietary supplement | Reformulated pizza |
| Control pizzaControl (placebo) meal to consume thrice weekly (no iodine supplementation). | Dietary supplement | Control pizza |
| Seaweed capsuleCapsules containing seaweed extract, the iodine-rich ingredient in the reformulated pizza, 400ug iodine per capsule, to be consumed three times per week (122% of weekly recommended intake). | Dietary supplement | Seaweed capsule |
| Control capsuleEmpty capsules (placebo) | Dietary supplement | Control capsule |
Primary outcome
Change in urinary iodine concentration (UIC)
Time frame: 0, 12 weeks
Change in UIC assessed in pooled spot urine samples at 12 weeks, from baseline
Change in urinary iodine concentration (UIC)
Time frame: 0, 24 weeks
Change in UIC assessed in pooled spot urine samples at 24 weeks, from baseline
9 secondary outcomes
Changes in body weight
Time frame: 0, 12, 24 weeks
Changes in body mass index
Time frame: 0, 12, 24 weeks
Changes in waist circumference
Time frame: 0, 12, 24 weeks
Concentration of thyroid stimulating hormone
Time frame: 0, 12, 24 weeks
Concentration of thyroglobulin
Time frame: 0, 12, 24 weeks
Concentration of Free Triiodothyronine
Time frame: 0, 12, 24 weeks
Concentration of Thyroxine
Time frame: 0, 12, 24 weeks
Dietary iodine intake
Time frame: 0, 12, 24 weeks
Change in urinary iodine concentration (UIC)
Time frame: 0, 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Individual participant dataSharing planned: No
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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 principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reformulated pizza and Seaweed capsule in people with Iodine Deficiency, run by University of Glasgow at 1 site in United Kingdom.
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 7 inclusion and 6 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: finished, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in urinary iodine concentration (UIC) (time frame: 0, 12 weeks). The study lists 2 primary outcomes in all. 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 9 Jan 2023.