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 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT06863935
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18-75 years with documented dyslipidemia (elevated triglycerides and/or LDL cholesterol).
* On stable lipid-lowering therapy (e.g., statins) or lifestyle regimen for at least 4 weeks prior to enrollment, if applicable.
* Willingness to undergo genetic testing for FADS1/FADS2 variants. For the FADS Variant Cohort: confirmed homozygous (or high-risk) polymorphisms in FADS1/FADS2.
* For the Non-Variant Cohort: confirmed wild-type FADS genotype.
Exclusion Criteria:
* Use of prescription omega-3 products or high-dose fish oil supplements within 4 weeks prior to enrollment.
* Known hypersensitivity to fish or fish oil products. Significant renal or hepatic impairment, uncontrolled thyroid disease, or other comorbidities that may confound results.
* Pregnancy or breastfeeding.
* Inability or unwillingness to comply with study procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06863935
Study Brief:
Protocol Section:
NCT06863935