- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02148835
Influence of Dietary Omega-3 Fatty Acids in Various triOMEG Sausages on the HS-Omega-3 Index in Healthy Individuals
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bavaria
-
Munich, Bavaria, Germany, 80336
- Dept. of Preventive Cardiology, Ludwig Maximilians-University Munich
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects must be willing to eat 80 g of the sausage to be investigated per day.
- Age: 20 - 60 years
- Low HS-Omega-3 Index (<5%)
- Subjects must have adequate fluency in German or English to complete baseline and follow-up interviews.
- Stable intake of food containing EPA+DHA before and during study
- Subjects must be able and willing to give written informed consent, and to comply with study procedures.
Exclusion Criteria:
- 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 consuming >2 portions of fatty fish / week
- 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.
- Subjects with any acute and life-threatening condition, such as collapse and shock, acute myocardial infarction (last three months), stroke, embolism.
- 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.
- 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 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.
- Use of any investigational agents within 30 days prior to t0
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Triomeg
Sausage: Triomeg
|
Commercial sausages enriched with 330 - 510 mg EPA+DHA / 100 g Approximate average composition of active product per 80 g Sausage (Triomeg): 250 mg EPA+DHA as ethyl-ester Energy content 500 kJ (120 kcal), protein 12 g, Carbohydrates 0.8 g, total fat 9 g, of which 2.8 g saturated fatty acids, 4.5 g monounsaturates, 1.4 g polyunsaturates.
sodium 0.66 g.
|
Placebo Comparator: Control sausage
Sausage: Control
|
Control sausage: as active, but no EPA+DHA ethyl-ester.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HS-Omega-3 Index at Baseline and End of Study
Time Frame: baseline and 8 weeks
|
The HS-Omega-3 Index is the percentage of EPA+DHA in erythrocytes, as assessed with a highly standardized analytical procedure.
Since the HS-Omega-3 Index correlates with tissue EPA+DHA, it represents an individual's status in EPA+DHA.
|
baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and Palatability of the Study Sausage
Time Frame: 10 weeks
|
Serious adverse events (SAE) not necessarily ending study participation are:
Moreover, all other medical events will be recorded. All events qualifying as AE or SAE, according to Good Clinical Practice, will be recorded and reported to the ethic´s committee. |
10 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anton Köhler, MD, Ludwig-Maximilians - University of Munich
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 543-13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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