Iodine DeficiencyIoBIONCT06775795
The Bioavailability of Iodine in Plant-based Milk Alternatives
A study testing Oat milk, Soya milk and Cow's milk in people with Iodine Deficiency, run by University of Surrey at 1 site in United Kingdom.
Trial summary
Iodine is a mineral commonly found in seafood and dairy products such as milk and cheese. Iodine is important as it is required to make thyroid hormones which regulate growth and metabolism at all stages of life. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Iodine Deficiency
- What is being tested?
- Oat milk, Soya milk and Cow's milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-reported healthy adults
- Aged 18+
- English speakers
- Signed consent form
- No allergies or intolerances to the study drinks
- Not following a vegan diet (participants will be required to drink cow's milk)
Who cannot join
- Pregnancy or lactating (according to the participants own statement)
- Living outside of the UK
- Involvement in another research study where diet is restricted or modified
- History of thyroid disease (according to the participants own statement)
- Any metabolic, gastrointestinal or chronic disease such as diabetes, hepatitis, hypertension, or cancer (according to the participants own statement)
- Use of iodine containing supplements within 1 week prior to study start
Show all 9Show fewer
- Inadequate (<70 µg/day) or excessive (>500 µg/day) iodine intake from food (assessed during screening with previously validated iodine-specific FFQ)
- Use of iodine-containing disinfectants (betadine)
- Exposure to iodine-containing X-ray/ computed tomography contrast agent within the last month
Trial locations and contacts
1 site in 1 country.
About this study
Iodine is a mineral commonly found in seafood and dairy products such as milk and cheese. Iodine is important as it is required to make thyroid hormones which regulate growth and metabolism at all stages of life. The UK population has been iodine-sufficient for many years, however, there is now concern that iodine deficiency may be more prevalent than previously thought. This is a concern because iodine deficiency during pregnancy can result in cognitive impairment and developmental delays in children.
This study will to measure the ability to absorb iodine from plant-based milk alternatives fortified with iodine and compare with cow's milk in adults. Knowing the actual iodine bioavailability from plant-based alternatives is important because plant-based milk alternatives are becoming increasingly popular, especially in young adults, and are used as a replacement for cow's milk.
In this study, participants will consume three test drinks (cow's milk, soya milk and oat milk), one per week. The study will start with the cows' milk and the other two drinks will be administered in a random order with a crossover design. We will ask participants to follow a low iodine diet for three days leading up to the test day where they will drink one of the test drinks. Participants will then keep a food diary and collect their urine for the following 24 hours. Participants will then go back to their usual diet for at least four days before starting the next arm of the study with another test drink. This data will be used to calculate how much iodine was absorbed.
- Conditions
- Iodine Deficiency
- Being tested
- Oat milk, Soya milk, Cow's milk
- Keywords
- iodine bioavailability, iodine, milk, plant-based
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oat milkDietary supplement
Participants will consume one portion of plant-based milk alternative (oat) which will provide approximately 200 µg of iodine
Soya milkDietary supplement
Participants will consume one portion of plant-based milk alternative (soya) which will provide approximately 200 µg of iodine
Cow's milkDietary supplement
Participants will consume one portion of semi-skimmed cow's milk which will provide approximately 200 µg of iodine
| Study group | Role | What they receive |
|---|---|---|
| Cow's milk | Active comparator | Semi-Skimmed UHT Milk (estimated iodine concentration: 350 µg/L) providing approximately 200 µg of iodine (approx. 570mL). Receives: Dietary Supplement: Cow's milk |
| Oat milk alternative | Experimental | Oat Drink (estimated iodine concentration: 370 µg/L) providing approximately 200 µg of iodine (approx. 545mL). Receives: Dietary Supplement: Oat milk |
| Soya milk alternative | Experimental | Soya Drink (estimated iodine concentration: 460 µg/L) providing approximately 200 µg of iodine (approx. 435mL). Receives: Dietary Supplement: Soya milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary iodine excretion
1 sport urine sample will be collected the day before test drink consumption and a 24-hour urine sample will be collected following the test drink consumption.
Measured: A single spot-urine sample collected on days: 2, 9, 16 Urine collected for 24 hours after consumption of test drink on days: 3, 10, 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start1 Jul 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775795
- Sponsor's protocol ID
- FHMS 23-24 161 EGA
- Acronym
- IoBIO
- Status last verified
- Jan 2025
- First submitted
- 3 Jan 2025
- Last updated
- 15 Jan 2025
- 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 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bioavailability of Iodine in Plant-based Milk Alternatives
- ClinicalTrials.gov ID
- NCT06775795
- Acronym / sponsor ID
- IoBIO / FHMS 23-24 161 EGA
- Conditions
- Iodine Deficiency
- Keywords
- iodine bioavailability, iodine, milk, plant-based
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 15 Jan 2025 (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.
Iodine is a mineral commonly found in seafood and dairy products such as milk and cheese. Iodine is important as it is required to make thyroid hormones which regulate growth and metabolism at all stages of life. The UK population has been iodine-sufficient for many years, however, there is now concern that iodine deficiency may be more prevalent than previously thought. This is a concern because iodine deficiency during pregnancy can result in cognitive impairment and developmental delays in children.
This study will to measure the ability to absorb iodine from plant-based milk alternatives fortified with iodine and compare with cow's milk in adults. Knowing the actual iodine bioavailability from plant-based alternatives is important because plant-based milk alternatives are becoming increasingly popular, especially in young adults, and are used as a replacement for cow's milk.
In this study, participants will consume three test drinks (cow's milk, soya milk and oat milk), one per week. The study will start with the cows' milk and the other two drinks will be administered in a random order with a crossover design. We will ask participants to follow a low iodine diet for three days leading up to the test day where they will drink one of the test drinks. Participants will then keep a food diary and collect their urine for the following 24 hours. Participants will then go back to their usual diet for at least four days before starting the next arm of the study with another test drink. This data will be used to calculate how much iodine was absorbed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cow's milk | Active comparator | Dietary Supplement: Cow's milkSemi-Skimmed UHT Milk (estimated iodine concentration: 350 µg/L) providing approximately 200 µg of iodine (approx. 570mL). |
| Oat milk alternative | Experimental | Dietary Supplement: Oat milkOat Drink (estimated iodine concentration: 370 µg/L) providing approximately 200 µg of iodine (approx. 545mL). |
| Soya milk alternative | Experimental | Dietary Supplement: Soya milkSoya Drink (estimated iodine concentration: 460 µg/L) providing approximately 200 µg of iodine (approx. 435mL). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Self-reported healthy adults
- Aged 18+
- English speakers
- Signed consent form
- No allergies or intolerances to the study drinks
Key exclusion criteria (9 listed)
- Pregnancy or lactating (according to the participants own statement)
- Living outside of the UK
- Involvement in another research study where diet is restricted or modified
- History of thyroid disease (according to the participants own statement)
- Any metabolic, gastrointestinal or chronic disease such as diabetes, hepatitis, hypertension, or cancer (according to the participants own statement)
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 |
|---|---|---|
| Oat milkParticipants will consume one portion of plant-based milk alternative (oat) which will provide approximately 200 µg of iodine | Dietary supplement | Oat milk alternative |
| Soya milkParticipants will consume one portion of plant-based milk alternative (soya) which will provide approximately 200 µg of iodine | Dietary supplement | Soya milk alternative |
| Cow's milkParticipants will consume one portion of semi-skimmed cow's milk which will provide approximately 200 µg of iodine | Dietary supplement | Cow's milk |
Primary outcome
Urinary iodine excretion
Time frame: A single spot-urine sample collected on days: 2, 9, 16 Urine collected for 24 hours after consumption of test drink on days: 3, 10, 17
1 sport urine sample will be collected the day before test drink consumption and a 24-hour urine sample will be collected following the test drink consumption.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oat milk, Soya milk and Cow's milk in people with Iodine Deficiency, run by University of Surrey 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 6 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 15 Jan 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Urinary iodine excretion (time frame: A single spot-urine sample collected on days: 2, 9, 16 Urine collected for 24 hours after consumption of test drink on days: 3, 10, 17). 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 15 Jan 2025.