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Macroalgae Consumption - a Pilot Study

Macroalgae Consumption - a Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05940727
Enrollment
49
Registered
2023-07-11
Start date
2022-01-01
Completion date
2023-01-01
Last updated
2023-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iodine Toxicity

Keywords

macroalgae, iodine, consumption

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.

Interventions

OTHERHabitual macroalgae consumption

The participant have a habitual macroalgae consumption at baseline.

OTHERNo macroalgae consumption

The participants exclude any macroalgae products from their diet

Sponsors

Institute of Marine Research
CollaboratorOTHER
University of Bergen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* adults * weekly consumer of macroalgae

Exclusion criteria

* pregnant * known disease

Design outcomes

Primary

MeasureTime frameDescription
Consumption of macroalgae productsThrough study completion, on average 6 weeksAssess 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 productsThrough study completion, on average 6 weeksAnalyse the levels of iodine, cadmium and inorganic arsenic in macroalgae products used by the participants

Secondary

MeasureTime frameDescription
Levels of inorganic arsenic in urine6 weeksAnalyse the levels of inorganic arsenic in urine after intervention/usual macroalgae consumption
Levels of creatinine in urine6 weeksAnalyse the of creatinine in urine after intervention/usual macroalgae consumption
Thyroid function measure by thyroid-stimulating hormon6 weeksMeasurement of thyroid-stimulating hormon (TSH) in serum after intervention/usual macroalgae consumption
Thyroid function measure by ree-triiodinetyronin6 weeksMeasurement of free-triiodinetyronin (fT3) in serum after intervention/usual macroalgae consumption
Levels of iodine6 weeksAnalyse the levels of iodine in urine after intervention/usual macroalgae consumption
Thyroid function measure by Thyroid peroxidase antibody6 weeksMeasurement of Thyroid peroxidase antibody (TPOAb) in serum after intervention/usual macroalgae consumption
Thyroid function measured by thyroglobulin6 weeksMeasurement of thyroglobulin (Tg) in serum after intervention/usual macroalgae consumption
Thyroid function6 weeksMeasurement of thyroid-stimulating hormon (TSH), free-triiodinetyronin (fT3), free thyroxine (fT4), Thyroid peroxidase antibody (TPOAb), thyroglobulin (Tg) in serum after intervention/usual macroalgae consumption
Metabolic changes6 weeksMeasurement of metabolic changes by non-targeted metabolomics after intervention/usual macroalage consumption
Thyroid function measure by free thyroxine6 weeksMeasurement of free thyroxine (fT4) in serum after intervention/usual macroalgae consumption
Levels of cadmium in urine6 weeksAnalyse the levels of cadmium urine after intervention/usual macroalgae consumption

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026