Seaweed Iodine Delivered Via Food or Supplementation

Iodine Deficiency Clinical Trial

— INNOVATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04875377
• Other study ID #: 133109
• Status: Completed
• Phase: N/A
• Start date: February 12, 2018
• Est. completion date: September 5, 2019

Study information

• Verified date: January 2023
• Source: University of Glasgow
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: September 5, 2019
• Est. primary completion date: September 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Iodine Deficiency

Intervention

Dietary Supplement:
• Reformulated pizza
Reformulated food with 400ug of iodine per meal, three times per week (to achieve 122% of weekly recommended intakes - average 140ug/day).
• Control pizza
Control (placebo) meal to consume thrice weekly (no iodine supplementation).
• Seaweed capsule
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
Empty capsules (placebo)

Locations

Country	Name	City	State
United Kingdom	University of Glasgow	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	concentration of triglycerides	measured in blood	0, 12, 24 weeks
Other	concentration of total cholesterol	measured in blood	0, 12, 24 weeks
Other	concentration of HDL/LDL cholesterol	measured in blood	0, 12, 24 weeks
Other	glucose concentration	measured in blood	0, 12, 24 weeks
Primary	Change in urinary iodine concentration (UIC)	Change in UIC assessed in pooled spot urine samples at 12 weeks, from baseline	0, 12 weeks
Primary	Change in urinary iodine concentration (UIC)	Change in UIC assessed in pooled spot urine samples at 24 weeks, from baseline	0, 24 weeks
Secondary	Changes in body weight	Changes in body weight assessed from baseline at 12 and 24 weeks	0, 12, 24 weeks
Secondary	Changes in body mass index	Changes in body mass index assessed from baseline at 12 and 24 weeks	0, 12, 24 weeks
Secondary	Changes in waist circumference	Changes in waist circumference assessed from baseline at 12 and 24 weeks	0, 12, 24 weeks
Secondary	Concentration of thyroid stimulating hormone	measured by immunoassay	0, 12, 24 weeks
Secondary	Concentration of thyroglobulin	measured by immunoassay	0, 12, 24 weeks
Secondary	Concentration of Free Triiodothyronine	measured by immunoassay	0, 12, 24 weeks
Secondary	Concentration of Thyroxine	measured by immunoassay	0, 12, 24 weeks
Secondary	Dietary iodine intake	estimated by food frequency questionnaire (FFQ)	0, 12, 24 weeks
Secondary	Change in urinary iodine concentration (UIC)	Change in UIC assessed in pooled spot urine samples at 2 weeks, from baseline	0, 2 weeks