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:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT05650294
Eligibility Criteria:
Inclusion Criteria:
* Healthy males or females (1:1) aged 18 - 65 years
* Capable and willing to give written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
* Have a low habitual consumption of fatty fish and seafood, defined as a frequency of twice per month or less
* No fish consumption at least two weeks prior to screening visit
* Omega-3 index (≤ 7 %)
* Non-smoker
* BMI: 18 to 32 kg/m2
Exclusion Criteria:
* Omega-3 supplementation history within the last 4 weeks
* Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases, i.e., diabetes, cardiovascular, pulmonary, hematologic, gastrointestinal, neurological, or infectious diseases which could confound the results of the study or put the subject at undue risk
* Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 365 days prior to baseline
* Pregnancy, breast feeding or intention to become pregnant during the study (a pregnancy test will be conducted during screening and visits 1-2)
* General Safety \& Laboratory Exclusion Criteria. Patients will be excluded from the study based on the following criteria:
* Haemoglobin: \< 12.0 g/dL (women); \< 13.5 g/dL (men)
* Platelets: \< 150 x 103/μL
* Leukocytes \< 4,4 x 103/mm3
* Aspartate transaminase (AST) or alanine transaminase (ALT) within the normal range
* Serum creatine within the normal range
* or further for this study clinically relevant abnormal laboratory findings at screening
* Significant changes in lifestyle or medication (within last 2 months)
* Chronic intake of substances affecting blood coagulation (e.g. acetylic acid, anticoagulants (e.g. Marcumar), diuretics, thiazides), which in the investigator's opinion would impact subject safety
* Difficulty swallowing capsules or predicted inability to swallow the study products
* Individuals who have made a blood donation in excess of 500 mL or who had excess blood loss within the 4 months before the study starts
* Individuals who are currently enrolled in an ongoing clinical trial or who have been an active participant in a clinical trial within the last 4 weeks
* A known allergy or hypersensitivity to any of the ingredients of the study products
* Not willing to abstain from fish consumption or foods/oils high in omega-3 fatty acids
* Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05650294
Study Brief:
Protocol Section:
NCT05650294