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NCT Number: NCT06775795

The Bioavailability of Iodine in Plant-based Milk Alternatives

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Surrey

Guildford, GU2 7XH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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
  • 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

Treatment and study plan

oat milk

Dietary Supplement

Participants will consume one portion of plant-based milk alternative (oat) which will provide approximately 200 µg of iodine

Soya milk

Dietary Supplement

Participants will consume one portion of plant-based milk alternative (soya) which will provide approximately 200 µg of iodine

cow's milk

Dietary Supplement

Participants will consume one portion of semi-skimmed cow's milk which will provide approximately 200 µg of iodine

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Surrey

Other

Registry information

Acronym: IoBIO

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2025
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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