INNOVATE: Seaweed Iodine Delivered Via Food or Supplementation

Sponsor

University of Glasgow (Other)

Overall Status

Completed

CT.gov ID

NCT04875377

Collaborator

(none)

Enrollment

Location

Arms

18.7

Actual Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Iodine Deficiency	Dietary Supplement: Reformulated pizza Dietary Supplement: Control pizza Dietary Supplement: Seaweed capsule Dietary Supplement: Control capsule	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, double-blind, placebo-controlled trialRandomized, double-blind, placebo-controlled trial

Masking:

Double (Participant, Investigator)

Masking Description:

Masking of pizzas was achieved by the use of pizzas with identical appearance and taste. Iodine and control supplements were also identical in appearance. Both pizzas and supplements were provided to investigators already masked. Pizzas labelled X and Y. Supplements labelled A and B

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 12, 2018

Actual Primary Completion Date :

Sep 5, 2019

Actual Study Completion Date :

Sep 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Reformulated pizza Participants must consume a nutritionally balanced pizza reformulated with seaweed (Ascophyllum nodosum) as an ingredient 3 times a week for 24 weeks	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).
Placebo Comparator: Control pizza Participants must consume a nutritionally balanced pizza without seaweed, 3 times a week for 24 weeks	Dietary Supplement: Control pizza Control (placebo) meal to consume thrice weekly (no iodine supplementation).
Experimental: Seaweed capsule Participants must consume a capsule containing powdered Ascophyllum nodosum 3 times a week for 24 weeks	Dietary Supplement: 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).
Placebo Comparator: Control capsule Participants must consume an empty capsule 3 times a week for 24 weeks	Dietary Supplement: Control capsule Empty capsules (placebo)

Outcome Measures

Primary Outcome Measures

Change in urinary iodine concentration (UIC) [0, 12 weeks]
Change in UIC assessed in pooled spot urine samples at 12 weeks, from baseline
Change in urinary iodine concentration (UIC) [0, 24 weeks]
Change in UIC assessed in pooled spot urine samples at 24 weeks, from baseline

Secondary Outcome Measures

Changes in body weight [0, 12, 24 weeks]
Changes in body weight assessed from baseline at 12 and 24 weeks
Changes in body mass index [0, 12, 24 weeks]
Changes in body mass index assessed from baseline at 12 and 24 weeks
Changes in waist circumference [0, 12, 24 weeks]
Changes in waist circumference assessed from baseline at 12 and 24 weeks
Concentration of thyroid stimulating hormone [0, 12, 24 weeks]
measured by immunoassay
Concentration of thyroglobulin [0, 12, 24 weeks]
measured by immunoassay
Concentration of Free Triiodothyronine [0, 12, 24 weeks]
measured by immunoassay
Concentration of Thyroxine [0, 12, 24 weeks]
measured by immunoassay
Dietary iodine intake [0, 12, 24 weeks]
estimated by food frequency questionnaire (FFQ)
Change in urinary iodine concentration (UIC) [0, 2 weeks]
Change in UIC assessed in pooled spot urine samples at 2 weeks, from baseline

Other Outcome Measures

concentration of triglycerides [0, 12, 24 weeks]
measured in blood
concentration of total cholesterol [0, 12, 24 weeks]
measured in blood
concentration of HDL/LDL cholesterol [0, 12, 24 weeks]
measured in blood
glucose concentration [0, 12, 24 weeks]
measured in blood

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.