University of Bergen
Bergen, 5021, Norway
NCT Number: NCT05940727
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Bergen, 5021, Norway
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The participant have a habitual macroalgae consumption at baseline.
The participants exclude any macroalgae products from their diet
Time frame: Through study completion, on average 6 weeks
Assess the dietary consumption of macroalgae in consumers in the Bergen and Oslo area by 24hr recall and food frequency questionnaire
Time frame: Through study completion, on average 6 weeks
Analyse the levels of iodine, cadmium and inorganic arsenic in macroalgae products used by the participants
Time frame: 6 weeks
Analyse the levels of iodine in urine after intervention/usual macroalgae consumption
Time frame: 6 weeks
Analyse the levels of cadmium urine after intervention/usual macroalgae consumption
Time frame: 6 weeks
Analyse the levels of inorganic arsenic in urine after intervention/usual macroalgae consumption
Time frame: 6 weeks
Analyse the of creatinine in urine after intervention/usual macroalgae consumption
Time frame: 6 weeks
Measurement of thyroid-stimulating hormon (TSH) in serum after intervention/usual macroalgae consumption
Time frame: 6 weeks
Measurement of free-triiodinetyronin (fT3) in serum after intervention/usual macroalgae consumption
Time frame: 6 weeks
Measurement of free thyroxine (fT4) in serum after intervention/usual macroalgae consumption
Time frame: 6 weeks
Measurement of Thyroid peroxidase antibody (TPOAb) in serum after intervention/usual macroalgae consumption
Time frame: 6 weeks
Measurement of thyroglobulin (Tg) in serum after intervention/usual macroalgae consumption
Time frame: 6 weeks
Measurement of thyroid-stimulating hormon (TSH), free-triiodinetyronin (fT3), free thyroxine (fT4), Thyroid peroxidase antibody (TPOAb), thyroglobulin (Tg) in serum after intervention/usual macroalgae consumption
Time frame: 6 weeks
Measurement of metabolic changes by non-targeted metabolomics after intervention/usual macroalage consumption
University of Bergen
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.