Macroalgae Consumption - a Pilot Study

NCT ID: NCT05940727

Last Updated: 2023-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-01-01

Brief Summary

In this study, the aim is to investigate the food safety of macroalgae. There will be an analysis of macroalgae products for the concentration of cadmium, inorganic arsenic, and iodine in macroalgae, as well as measure the status of these elements in consumers. An investigation of the thyroid function of macroalgae consumers and the use of metabolomics to explore which biological changes occur when consuming seaweed and kelp and when the consumer excludes macroalgae from their diet will be performed.

Detailed Description

A group of consumers of macroalgae will be recruited to investigate their macroalgae intake and iodine, cadmium, and inorganic arsenic status and thyroid function. Iodine, cadmium, and inorganic arsenic have been selected since these elements have been described as relatively high in a previously published report from Norway. The goal is to recruit consumers of brown algae - especially kelp, and certain types of red algae, as these were the species with the highest content of iodine, cadmium, and arsenic, described in a previous publication. The participants will be asked to abstain from macroalgae for 6 weeks and again examine iodine status, cadmium and arsenic exposure, and thyroid function after the cessation period. A withdrawal period of 6 weeks has been chosen on the basis that it is calculated 6-8 weeks after Levaxin treatment for hypothyroidism before a new equilibrium can be expected and the effect of treatment on TSH can be assessed.

This study will provide new insight into the status of iodine, cadmium, and inorganic arsenic that macroalgae consumers have in urine and thyroid function after regular macroalgae consumption and after cessation of macroalgae intake. In addition, the study will provide descriptive data on macroalgae consumption, how it is eaten, how often, and how much. This can provide critical knowledge to the national and European authorities for food safety and public health advisers to evaluate the food safety of macroalgae.

Conditions

Iodine Toxicity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Usual macroalgae consumption

Crossover design with habitual macroalgae consumption at baseline

Group Type: ACTIVE_COMPARATOR

Habitual macroalgae consumption

Intervention Type: OTHER

The participant have a habitual macroalgae consumption at baseline.

No macroalgae consumption

Intervention Type: OTHER

The participants exclude any macroalgae products from their diet

Cessation of macroalgae consumption

Cessation of macroalgae consumption as an experimental intervention.

Group Type: EXPERIMENTAL

Habitual macroalgae consumption

Intervention Type: OTHER

The participant have a habitual macroalgae consumption at baseline.

No macroalgae consumption

Intervention Type: OTHER

The participants exclude any macroalgae products from their diet

Interventions

Habitual macroalgae consumption

The participant have a habitual macroalgae consumption at baseline.

Intervention Type: OTHER

No macroalgae consumption

The participants exclude any macroalgae products from their diet

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• adults
• weekly consumer of macroalgae

Exclusion Criteria

• pregnant
• known disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute of Marine Research

OTHER

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Inger Aakre, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Marine Research

Locations

University of Bergen

Bergen, , Norway

Countries

Norway

Other Identifiers

332865

Identifier Type: -

Identifier Source: org_study_id