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The Bioavailability of Iodine in Plant-based Milk Alternatives (IoBIO)

U

University of Surrey

Status

Active, not recruiting

Conditions

Iodine Deficiency

Treatments

Dietary Supplement: Cow's milk
Dietary Supplement: Oat milk
Dietary Supplement: Soya milk

Study type

Interventional

Funder types

Other

Identifiers

NCT06775795
FHMS 23-24 161 EGA

Details and patient eligibility

About

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.

Enrollment

17 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

17 participants in 3 patient groups

Cow's milk
Active Comparator group
Description:
Semi-Skimmed UHT Milk (estimated iodine concentration: 350 µg/L) providing approximately 200 µg of iodine (approx. 570mL).
Treatment:
Dietary Supplement: Cow's milk
Oat milk alternative
Experimental group
Description:
Oat Drink (estimated iodine concentration: 370 µg/L) providing approximately 200 µg of iodine (approx. 545mL).
Treatment:
Dietary Supplement: Oat milk
Soya milk alternative
Experimental group
Description:
Soya Drink (estimated iodine concentration: 460 µg/L) providing approximately 200 µg of iodine (approx. 435mL).
Treatment:
Dietary Supplement: Soya milk

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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