Skip to main content
OpenTrials
Completed

NCT Number: NCT05940727

Macroalgae Consumption - a Pilot Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bergen

Bergen, 5021, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults
  • weekly consumer of macroalgae

Exclusion criteria

  • pregnant
  • known disease

Treatment and study plan

Habitual macroalgae consumption

Other

The participant have a habitual macroalgae consumption at baseline.

No macroalgae consumption

Other

The participants exclude any macroalgae products from their diet

Primary outcomes

  1. Consumption of macroalgae products

    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

  2. Levels of iodine, cadmium and inorganic arsenic in macroalgae products

    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

Secondary outcomes

  1. Levels of iodine

    Time frame: 6 weeks

    Analyse the levels of iodine in urine after intervention/usual macroalgae consumption

  2. Levels of cadmium in urine

    Time frame: 6 weeks

    Analyse the levels of cadmium urine after intervention/usual macroalgae consumption

  3. Levels of inorganic arsenic in urine

    Time frame: 6 weeks

    Analyse the levels of inorganic arsenic in urine after intervention/usual macroalgae consumption

  4. Levels of creatinine in urine

    Time frame: 6 weeks

    Analyse the of creatinine in urine after intervention/usual macroalgae consumption

  5. Thyroid function measure by thyroid-stimulating hormon

    Time frame: 6 weeks

    Measurement of thyroid-stimulating hormon (TSH) in serum after intervention/usual macroalgae consumption

  6. Thyroid function measure by ree-triiodinetyronin

    Time frame: 6 weeks

    Measurement of free-triiodinetyronin (fT3) in serum after intervention/usual macroalgae consumption

  7. Thyroid function measure by free thyroxine

    Time frame: 6 weeks

    Measurement of free thyroxine (fT4) in serum after intervention/usual macroalgae consumption

  8. Thyroid function measure by Thyroid peroxidase antibody

    Time frame: 6 weeks

    Measurement of Thyroid peroxidase antibody (TPOAb) in serum after intervention/usual macroalgae consumption

  9. Thyroid function measured by thyroglobulin

    Time frame: 6 weeks

    Measurement of thyroglobulin (Tg) in serum after intervention/usual macroalgae consumption

  10. Thyroid function

    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

  11. Metabolic changes

    Time frame: 6 weeks

    Measurement of metabolic changes by non-targeted metabolomics after intervention/usual macroalage consumption

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Collaborators

  • Institute of Marine Research

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 11, 2023
Registry last updated
Jul 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.