Macroalgae Consumption - a Pilot Study

University of Bergen

Status: Completed

Conditions: Iodine Toxicity

Treatments: Other: Habitual macroalgae consumption; Other: No macroalgae consumption

Study type: Interventional

Funder types: Other

Identifiers

NCT05940727

332865

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• adults
• weekly consumer of macroalgae

Exclusion criteria

• pregnant
• known disease

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Usual macroalgae consumption

Active Comparator group

Description:

Crossover design with habitual macroalgae consumption at baseline

Treatment:

Other: No macroalgae consumption

Other: Habitual macroalgae consumption

Cessation of macroalgae consumption

Experimental group

Description:

Cessation of macroalgae consumption as an experimental intervention.

Treatment:

Other: No macroalgae consumption

Other: Habitual macroalgae consumption