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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT03897660
Eligibility Criteria:
Inclusion Criteria:
* Male or female aged 18-65 years (inclusive)
* Body mass index between 18.5 and 29.9 kg / m² (inclusive) at the pre-selection visit
* Normal to moderately elevated lipidemia (total cholesterol ≤ 240 mg / dl, LDL ≤ 160 mg / dl, TG ≤ 199 mg / dl)
* Women of childbearing potential should use an approved method of contraception for the duration of the study so that they do not become pregnant during the study
Exclusion Criteria:
* Menopause or pre-menopause with amenorrhea\> 6 months
* Tobacco
* Malnutrition (assessed by albumin, hemoglobin and blood lipid levels)
* DHA plasma levels greater than 3% or people consuming omega-3 fatty acid supplements for more than one month
* History of current or past alcohol and / or drug abuse
* Parkinson's disease
* Down syndrome
* Cardiac event or recent major surgery (6 months)
* Current or past performance athlete
* Systemic disease: vasculitis, Systemic Lupus Erythematosus (SLE), sarcoidosis, cancer (unless in remission for more than 5 years and without cerebral involvement), uncompensated hypothyroidism (unless stabilized on treatment for more than 3 months), vitamin deficiency B12 not supplemented and / or complicated (unless stabilized on treatment for more than 3 months), diabetes, severe renal insufficiency
* Abnormal blood pressure and / or liver, renal or thyroid function; these conditions will not exclude a patient if he has been stabilized on treatment for at least 3 months and there has been no recent change in the medication.
* Known psychiatric history: schizophrenia, psychotic disorders, major affective disorders (bipolar disorder and major depression \<5 years), panic disorder, Obsessive Compulsive Disorder (OCD)
* Epilepsy, cerebral trauma with loss of consciousness, subarachnoid hemorrhage
* Not available to perform the 3 different treatments
* Medication affecting fat absorption (i.e., Orlistat, Alli, etc.), which interferes with omega-3 fatty acids uptake (i.e., anticoagulants) or which affects lipid metabolism (i.e., all types of drug for decrease cholesterol or triglycerides)
* Nobody under a special diet like a fat-free, vegetarian or vegan diet
* People who have a malabsorption disease such as pancreatitis, Crohn's disease or who have had bariatric surgery.
* Allergy to fish or seafood
* Pregnant women or nursing women
* Person who donated blood or had significant blood loss in the 30 days prior to study start
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03897660
Study Brief:
Protocol Section:
NCT03897660