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Completed

NCT Number: NCT04875377

Seaweed Iodine Delivered Via Food or Supplementation

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.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Glasgow

Glasgow, G31 2ER, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.

Treatment and study plan

Reformulated pizza

Dietary Supplement

Reformulated food with 400ug of iodine per meal, three times per week (to achieve 122% of weekly recommended intakes - average 140ug/day).

Control pizza

Dietary Supplement

Control (placebo) meal to consume thrice weekly (no iodine supplementation).

Seaweed capsule

Dietary 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 capsule

Dietary Supplement

Empty capsules (placebo)

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Changes in body weight

    Time frame: 0, 12, 24 weeks

    Changes in body weight assessed from baseline at 12 and 24 weeks

  2. Changes in body mass index

    Time frame: 0, 12, 24 weeks

    Changes in body mass index assessed from baseline at 12 and 24 weeks

  3. Changes in waist circumference

    Time frame: 0, 12, 24 weeks

    Changes in waist circumference assessed from baseline at 12 and 24 weeks

  4. Concentration of thyroid stimulating hormone

    Time frame: 0, 12, 24 weeks

    measured by immunoassay

  5. Concentration of thyroglobulin

    Time frame: 0, 12, 24 weeks

    measured by immunoassay

  6. Concentration of Free Triiodothyronine

    Time frame: 0, 12, 24 weeks

    measured by immunoassay

  7. Concentration of Thyroxine

    Time frame: 0, 12, 24 weeks

    measured by immunoassay

  8. Dietary iodine intake

    Time frame: 0, 12, 24 weeks

    estimated by food frequency questionnaire (FFQ)

  9. Change in urinary iodine concentration (UIC)

    Time frame: 0, 2 weeks

    Change in UIC assessed in pooled spot urine samples at 2 weeks, from baseline

Other outcomes

  1. concentration of triglycerides

    Time frame: 0, 12, 24 weeks

    measured in blood

  2. concentration of total cholesterol

    Time frame: 0, 12, 24 weeks

    measured in blood

  3. concentration of HDL/LDL cholesterol

    Time frame: 0, 12, 24 weeks

    measured in blood

  4. glucose concentration

    Time frame: 0, 12, 24 weeks

    measured in blood

Sponsors and collaborators

Lead sponsor

University of Glasgow

Other

Registry information

Official study title

Iodine From Seaweed - a Randomised Controlled Trial of Food Versus Supplementation in Women With Marginal Habitual Iodine Intake

Acronym: INNOVATE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 6, 2021
Registry last updated
Jan 9, 2023

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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