Recruitment

Recruitment Status
Completed

Inclusion Criteria

Subjects must be able and willing to give written informed consent, and to comply with study procedures.
Subjects must have adequate fluency in German or English to complete baseline and follow-up interviews.
Subjects must be willing to eat 80 g of the sausage to be investigated per day.
...
Subjects must be able and willing to give written informed consent, and to comply with study procedures.
Subjects must have adequate fluency in German or English to complete baseline and follow-up interviews.
Subjects must be willing to eat 80 g of the sausage to be investigated per day.
Stable intake of food containing EPA+DHA before and during study
Low HS-Omega-3 Index (<5%)
Age: 20 - 60 years

Exclusion Criteria

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 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 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.
Use of any investigational agents within 30 days prior to t0
Subjects consuming >2 portions of fatty fish / week
Subjects with any acute and life-threatening condition, such as collapse and shock, acute myocardial infarction (last three months), stroke, embolism.
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.
Subjects with significant medical co-morbidity, seriously limiting life expectancy or insulin-treated diabetes mellitus or a BMI>30
Allergy/intolerance or history of hypersensitivity to components of study intervention.

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

Subjects must be able and willing to give written informed consent, and to comply with study procedures.
Subjects must have adequate fluency in German or English to complete baseline and follow-up interviews.
Subjects must be willing to eat 80 g of the sausage to be investigated per day.
...
Subjects must be able and willing to give written informed consent, and to comply with study procedures.
Subjects must have adequate fluency in German or English to complete baseline and follow-up interviews.
Subjects must be willing to eat 80 g of the sausage to be investigated per day.
Stable intake of food containing EPA+DHA before and during study
Low HS-Omega-3 Index (<5%)
Age: 20 - 60 years

Exclusion Criteria

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 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 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.
Use of any investigational agents within 30 days prior to t0
Subjects consuming >2 portions of fatty fish / week
Subjects with any acute and life-threatening condition, such as collapse and shock, acute myocardial infarction (last three months), stroke, embolism.
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.
Subjects with significant medical co-morbidity, seriously limiting life expectancy or insulin-treated diabetes mellitus or a BMI>30
Allergy/intolerance or history of hypersensitivity to components of study intervention.

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
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