NCT05940727

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

12 months

First QC Date

March 6, 2023

Last Update Submit

July 3, 2023

Conditions

Iodine Toxicity

Keywords

macroalgaeiodineconsumption

Outcome Measures

Primary Outcomes (2)

  • Consumption of macroalgae products

    Assess the dietary consumption of macroalgae in consumers in the Bergen and Oslo area by 24hr recall and food frequency questionnaire

    Through study completion, on average 6 weeks

  • Levels of iodine, cadmium and inorganic arsenic in macroalgae products

    Analyse the levels of iodine, cadmium and inorganic arsenic in macroalgae products used by the participants

    Through study completion, on average 6 weeks

Secondary Outcomes (11)

  • Levels of iodine

    6 weeks

  • Levels of cadmium in urine

    6 weeks

  • Levels of inorganic arsenic in urine

    6 weeks

  • Levels of creatinine in urine

    6 weeks

  • Thyroid function measure by thyroid-stimulating hormon

    6 weeks

  • +6 more secondary outcomes

Study Arms (2)

Usual macroalgae consumption

ACTIVE COMPARATOR

Crossover design with habitual macroalgae consumption at baseline

Other: Habitual macroalgae consumptionOther: No macroalgae consumption

Cessation of macroalgae consumption

EXPERIMENTAL

Cessation of macroalgae consumption as an experimental intervention.

Other: Habitual macroalgae consumptionOther: No macroalgae consumption

Interventions

Habitual macroalgae consumptionOTHER

The participant have a habitual macroalgae consumption at baseline.

Cessation of macroalgae consumptionUsual macroalgae consumption
No macroalgae consumptionOTHER

The participants exclude any macroalgae products from their diet

Cessation of macroalgae consumptionUsual macroalgae consumption

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults
  • weekly consumer of macroalgae

You may not qualify if:

  • pregnant
  • known disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bergen

Bergen, 5021, Norway

Location

Study Officials

  • Inger Aakre, PhD

    Institute of Marine Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2023

First Posted

July 11, 2023

Study Start

January 1, 2022

Primary Completion

December 15, 2022

Study Completion

January 1, 2023

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)