Clinical trial NCT05940727: Macroalgae Consumption - a Pilot Study
Official title: Macroalgae Consumption - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iodine Toxicity
Keywords: macroalgae
iodine
consumption
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Institute of Marine Research
First posted: 2023-07-11
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* adults
* weekly consumer of macroalgae

Exclusion Criteria:

* pregnant
* known disease

Primary outcomes:
measure: Consumption of macroalgae products
timeFrame: Through study completion, on average 6 weeks
measure: Levels of iodine, cadmium and inorganic arsenic in macroalgae products
timeFrame: Through study completion, on average 6 weeks
Secondary outcomes:
measure: Levels of iodine
timeFrame: 6 weeks
measure: Levels of cadmium in urine
timeFrame: 6 weeks
measure: Levels of inorganic arsenic in urine
timeFrame: 6 weeks
measure: Levels of creatinine in urine
timeFrame: 6 weeks
measure: Thyroid function measure by thyroid-stimulating hormon
timeFrame: 6 weeks
measure: Thyroid function measure by ree-triiodinetyronin
timeFrame: 6 weeks
measure: Thyroid function measure by free thyroxine
timeFrame: 6 weeks
measure: Thyroid function measure by Thyroid peroxidase antibody
timeFrame: 6 weeks
measure: Thyroid function measured by thyroglobulin
timeFrame: 6 weeks
measure: Thyroid function
timeFrame: 6 weeks
measure: Metabolic changes
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: University of Bergen
Study officials:
affiliation: Institute of Marine Research
name: Inger Aakre, PhD
role: PRINCIPAL_INVESTIGATOR
References: