Macroalgae Consumption - a Pilot Study
- Conditions
- Iodine Toxicity
- Interventions
- Other: Habitual macroalgae consumptionOther: No macroalgae consumption
- Registration Number
- NCT05940727
- Lead Sponsor
- University of Bergen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
- adults
- weekly consumer of macroalgae
- pregnant
- known disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Usual macroalgae consumption No macroalgae consumption Crossover design with habitual macroalgae consumption at baseline Usual macroalgae consumption Habitual macroalgae consumption Crossover design with habitual macroalgae consumption at baseline Cessation of macroalgae consumption Habitual macroalgae consumption Cessation of macroalgae consumption as an experimental intervention. Cessation of macroalgae consumption No macroalgae consumption Cessation of macroalgae consumption as an experimental intervention.
- Primary Outcome Measures
Name Time Method Consumption of macroalgae products 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
Levels of iodine, cadmium and inorganic arsenic in macroalgae products Through study completion, on average 6 weeks Analyse the levels of iodine, cadmium and inorganic arsenic in macroalgae products used by the participants
- Secondary Outcome Measures
Name Time Method Levels of cadmium in urine 6 weeks Analyse the levels of cadmium urine after intervention/usual macroalgae consumption
Levels of inorganic arsenic in urine 6 weeks Analyse the levels of inorganic arsenic in urine after intervention/usual macroalgae consumption
Levels of creatinine in urine 6 weeks Analyse the of creatinine in urine after intervention/usual macroalgae consumption
Levels of iodine 6 weeks Analyse the levels of iodine in urine after intervention/usual macroalgae consumption
Metabolic changes 6 weeks Measurement of metabolic changes by non-targeted metabolomics after intervention/usual macroalage consumption
Thyroid function measure by thyroid-stimulating hormon 6 weeks Measurement of thyroid-stimulating hormon (TSH) in serum after intervention/usual macroalgae consumption
Thyroid function measure by ree-triiodinetyronin 6 weeks Measurement of free-triiodinetyronin (fT3) in serum after intervention/usual macroalgae consumption
Thyroid function measure by free thyroxine 6 weeks Measurement of free thyroxine (fT4) in serum after intervention/usual macroalgae consumption
Thyroid function measured by thyroglobulin 6 weeks Measurement of thyroglobulin (Tg) in serum after intervention/usual macroalgae consumption
Thyroid function measure by Thyroid peroxidase antibody 6 weeks Measurement of Thyroid peroxidase antibody (TPOAb) in serum after intervention/usual macroalgae consumption
Thyroid function 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
Trial Locations
- Locations (1)
University of Bergen
🇳🇴Bergen, Norway