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临床试验/NCT06775795
NCT06775795进行中(未招募)不适用

The Bioavailability of Iodine in Plant-based Milk Alternatives

University of Surrey1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2024年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
17
试验地点
1
主要终点
Urinary iodine excretion

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Self-reported healthy adults
  • •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)

排除标准

  • •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

研究组 & 干预措施

Oat milk alternative

Experimental

Oat Drink (estimated iodine concentration: 370 µg/L) providing approximately 200 µg of iodine (approx. 545mL).

干预措施: Oat milk (Dietary Supplement)

Soya milk alternative

Experimental

Soya Drink (estimated iodine concentration: 460 µg/L) providing approximately 200 µg of iodine (approx. 435mL).

干预措施: Soya milk (Dietary Supplement)

Cow's milk

Active Comparator

Semi-Skimmed UHT Milk (estimated iodine concentration: 350 µg/L) providing approximately 200 µg of iodine (approx. 570mL).

干预措施: Cow's milk (Dietary Supplement)

结局指标

主要结局

Urinary iodine excretion

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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