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 @ 10:13 PM
Ignite Modification Date:
2025-12-24 @ 10:13 PM
NCT ID:
NCT02148835
Eligibility Criteria:
Inclusion Criteria:
1. Subjects must be willing to eat 80 g of the sausage to be investigated per day.
2. Age: 20 - 60 years
3. Low HS-Omega-3 Index (\<5%)
4. Subjects must have adequate fluency in German or English to complete baseline and follow-up interviews.
5. Stable intake of food containing EPA+DHA before and during study
6. Subjects must be able and willing to give written informed consent, and to comply with study procedures.
Exclusion Criteria:
1. Subjects for whom the intake of omega-3 fatty acids is mandatory according to recent treatment guidelines or who take omega-3 fatty acids supplements on a regular basis.
2. Subjects consuming \>2 portions of fatty fish / week
3. Subjects with serious bleeding disorder. Use of platelet inhibitors or conventional anticoagulation with a target INR of 2.0 - 3.0 is not an exclusion criterion.
4. Subjects with any acute and life-threatening condition, such as collapse and shock, acute myocardial infarction (last three months), stroke, embolism.
5. Subjects with significant medical co-morbidity, seriously limiting life expectancy or insulin-treated diabetes mellitus or a BMI\>30
6. Allergy/intolerance or history of hypersensitivity to components of study intervention.
7. Pregnant subjects and breastfeeding subjects. In addition, women of childbearing potential who will not practice a medically accepted method of contraception will be excluded.
8. Subjects who, in the investigator's judgement, will not likely be able to comply with the study protocol or with known drug- or alcohol abuse/dependence in the past 2 years.
9. Use of any investigational agents within 30 days prior to t0
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
60 Years
Study:
NCT02148835
Study Brief:
Protocol Section:
NCT02148835