Influence of Dietary Omega-3 Fatty Acids in Various triOMEG Sausages on the HS-Omega-3 Index in Healthy Individuals
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- Stable intake of food containing EPA+DHA before and during study
- Subjects must have adequate fluency in German or English to complete baseline and follow-up interviews.
- Subjects must be able and willing to give written informed consent, and to comply with study procedures.
- ...
- Stable intake of food containing EPA+DHA before and during study
- Subjects must have adequate fluency in German or English to complete baseline and follow-up interviews.
- Subjects must be able and willing to give written informed consent, and to comply with study procedures.
- Low HS-Omega-3 Index (<5%)
- Age: 20 - 60 years
- Subjects must be willing to eat 80 g of the sausage to be investigated per day.
Exclusion Criteria
- 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.
- Allergy/intolerance or history of hypersensitivity to components of study intervention.
- Subjects consuming >2 portions of fatty fish / week
- ...
- 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.
- Allergy/intolerance or history of hypersensitivity to components of study intervention.
- Subjects consuming >2 portions of fatty fish / week
- 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.
- 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.
- Pregnant subjects and breastfeeding subjects. In addition, women of childbearing potential who will not practice a medically accepted method of contraception will be excluded.
- Subjects with any acute and life-threatening condition, such as collapse and shock, acute myocardial infarction (last three months), stroke, embolism.
- Use of any investigational agents within 30 days prior to t0
- Subjects with significant medical co-morbidity, seriously limiting life expectancy or insulin-treated diabetes mellitus or a BMI>30
Summary
- Conditions
- Healthy Volunteers
- Type
- Interventional
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Other
Participation Requirements
- Age
- Between 20 years and 60 years
- Gender
- Both males and females
Description
Randomized, placebo-controlled, mono-center comparison of two matching groups of sausages (active vs. control). The study will be conducted according to Good Clinical Practice. Randomization will be computer-generated by the sponsor. Sealed envelopes will be provided to the Investigator bearing indi...
Randomized, placebo-controlled, mono-center comparison of two matching groups of sausages (active vs. control). The study will be conducted according to Good Clinical Practice. Randomization will be computer-generated by the sponsor. Sealed envelopes will be provided to the Investigator bearing individual randomization numbers, containing individual randomization results. Thus, in case of need, one sealed envelope can be opened to learn the randomization result of one patient without overall unblinding. Study participants will be requested to ingest approx. 80 g / day of the experimental sausages during the day at a time of their convenience. Study participants will be provided with the investigational product free of charge. If necessary, the investigational product will be shipped to study participants. Study participants will receive the exact amount of sausages to complete the study.
Inclusion Criteria
- Stable intake of food containing EPA+DHA before and during study
- Subjects must have adequate fluency in German or English to complete baseline and follow-up interviews.
- Subjects must be able and willing to give written informed consent, and to comply with study procedures.
- ...
- Stable intake of food containing EPA+DHA before and during study
- Subjects must have adequate fluency in German or English to complete baseline and follow-up interviews.
- Subjects must be able and willing to give written informed consent, and to comply with study procedures.
- Low HS-Omega-3 Index (<5%)
- Age: 20 - 60 years
- Subjects must be willing to eat 80 g of the sausage to be investigated per day.
Exclusion Criteria
- 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.
- Allergy/intolerance or history of hypersensitivity to components of study intervention.
- Subjects consuming >2 portions of fatty fish / week
- ...
- 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.
- Allergy/intolerance or history of hypersensitivity to components of study intervention.
- Subjects consuming >2 portions of fatty fish / week
- 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.
- 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.
- Pregnant subjects and breastfeeding subjects. In addition, women of childbearing potential who will not practice a medically accepted method of contraception will be excluded.
- Subjects with any acute and life-threatening condition, such as collapse and shock, acute myocardial infarction (last three months), stroke, embolism.
- Use of any investigational agents within 30 days prior to t0
- Subjects with significant medical co-morbidity, seriously limiting life expectancy or insulin-treated diabetes mellitus or a BMI>30
Tracking Information
- NCT #
- NCT02148835
- Collaborators
- Südbayerische Fleischwaren GmbH
- Investigators
- Principal Investigator: Anton Köhler, MD Ludwig-Maximilians - University of Munich
- Anton Köhler, MD Ludwig-Maximilians - University of Munich