Seaweed Iodine Delivered Via Food or Supplementation

NCT04875377 | Completed

• 1 other identifier: 133109
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Iodine Deficiency

Keywords

iodine; seaweed; supplementation; reformulation; food matrix; thyroid function

Outcome Measures

Primary Outcomes (2)

• Change in urinary iodine concentration (UIC)

  Change in UIC assessed in pooled spot urine samples at 12 weeks, from baseline

  0, 12 weeks

• Change in urinary iodine concentration (UIC)

  Change in UIC assessed in pooled spot urine samples at 24 weeks, from baseline

  0, 24 weeks

Secondary Outcomes (9)

• Changes in body weight

  0, 12, 24 weeks

• Changes in body mass index

  0, 12, 24 weeks

• Changes in waist circumference

  0, 12, 24 weeks

• Concentration of thyroid stimulating hormone

  0, 12, 24 weeks

• Concentration of thyroglobulin

  0, 12, 24 weeks

Other Outcomes (4)

• concentration of triglycerides

  0, 12, 24 weeks

• concentration of total cholesterol

  0, 12, 24 weeks

• concentration of HDL/LDL cholesterol

  0, 12, 24 weeks

Study Arms (4)

Reformulated pizza

EXPERIMENTAL

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

Control pizza

PLACEBO COMPARATOR

Participants must consume a nutritionally balanced pizza without seaweed, 3 times a week for 24 weeks

Dietary Supplement: Control pizza

Seaweed capsule

EXPERIMENTAL

Participants must consume a capsule containing powdered Ascophyllum nodosum 3 times a week for 24 weeks

Dietary Supplement: Seaweed capsule

Control capsule

PLACEBO COMPARATOR

Participants must consume an empty capsule 3 times a week for 24 weeks

Dietary Supplement: Control capsule

Interventions

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).

Reformulated pizza

Control pizza DIETARY_SUPPLEMENT

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

Control pizza

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).

Seaweed capsule

Control capsule DIETARY_SUPPLEMENT

Empty capsules (placebo)

Control capsule

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Glasgow: lead

Study Sites (1)

University of Glasgow

Glasgow, G31 2ER, United Kingdom

Location

Study Officials

• Emilie Combet

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, double-blind, placebo-controlled trial

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 6, 2021
• Study Start: February 12, 2018
• Primary Completion: September 5, 2019
• Study Completion: September 5, 2019
• Last Updated: January 9, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)