Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2025-12-24 @ 3:52 PM
NCT ID:
NCT05149092
Eligibility Criteria:
Inclusion Criteria:
* Female and male subjects at least 20 years old understanding Norwegian oral and written information
* Waist circumference of:
* Men \> 95 cm
* Women \> 81 cm
Exclusion Criteria:
* Pregnancy
* Having used high-dose omega-3 PUFA supplements (\>2 g/day) 28 days' prior to randomization
* Alcohol or drug abuse or any conditions associated with poor compliance
* Scheduled hospitalization during the course of the study that could compromise the study
* Major diseases or infections including chronic diseases
* Known or suspected sensitivity or allergic reactions to the IMP or excipients
* Presence of other major medical or psychiatric illness that would affect the ability to participate in the study or put the subject at increased risk
* Intake of statins. If needed to obtain the recruitment goals, we will accept people using a low dose of statin. Simvastatin 10 mg or Pravastatin 10-20 mg will be accepted, but not higher doses or the drugs Lipitor/Atorvastatin and Crestor/Rosuvastatin.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT05149092
Study Brief:
Protocol Section:
NCT05149092