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 @ 12:15 PM
Ignite Modification Date:
2025-12-24 @ 12:15 PM
NCT ID:
NCT06150261
Eligibility Criteria:
Inclusion Criteria:
* Aged 55 or more
* BMI between 25-30,
* Waist-to-hip ratio of at least 0.90 (males) or 0.85 (females)
* Omega-3 index \<6
Exclusion Criteria:
* Dementia
* Current clinically significant depression, i.e. major depression or GDS 15 score \>7
* Ischemic or haemorrhagic Stroke
* Acute myocardial infarction
* Any form of clinically significant atherosclerotic cardiovascular disease
* Unstable angina pectoris
* Hearth failure in need of treatment
* Diabetes mellitus type 1 or 2
* Clinically relevant kidney diseases that require dialysis, including clinically significant chronic kidney disease
* Liver cirrhosis or active hepatitis B or C
* Cancer of any kind; however, benign tumours are no exclusion criterium
* Clinically relevant inflammatory or autoimmune disorders with history of hospitalisation
* Any form of systemic lupus erythematosus (SLE), rheumatoid arthritis, Colitis ulcerosa, Crohn's disease, Morbus Parkinson, Multiple Sclerosis
* hsCRP \> 3.0 mg/L to exclude high risk individuals according to international criteria
* LDL-C \> 160mg/dL to exclude individuals with high risk for arterioscleratic coronary disease26
* HBa1C \< 6.5% to exclude diabetes
* Fasting Triglycerides \>200 mg/dL
* Omega 3 index \> 6 % (as they may not show any benefit from supplementation)
* Use of fish oil / omega 3 supplements over the last 6 months
* Fish allergy
* Antibiotic use in the last 24 weeks
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
100 Years
Study:
NCT06150261
Study Brief:
Protocol Section:
NCT06150261