N/A
Completed N=44
Influence of Dietary Omega-3 Fatty Acids in Various triOMEG Sausages on the HS-Omega-3 Index in Healthy Individuals
Healthy Volunteers
Source: ClinicalTrials.gov NCT02148835 ↗
Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcomePrimary: HS-Omega-3 Index at Baseline and End of Study — 4.18; 4.32; 5.72; 4.50 HS-Omega-3 Index
Summary
New approaches to increase eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in our diet are needed, but any new approach needs to demonstrate the bioavailability of EPA+DHA, and its safety and palatability. The HS-Omega-3 Index is a prime parameter to demonstrate bioavailability in the long-term. Study hypothesis is that increased intake of EPA+DHA will increase the HS-Omega-3 Index. Study aim is to investigate how supplementing various sausages with omega-3 fatty acids influences the HS-Omega-3 Index in healthy volunteers, as compared to unsupplemented matching sausages. Safety and palatability of the sausages are also to be assessed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HS-Omega-3 Index at Baseline and End of Study |
4.18; 4.32; 5.72; 4.50 | — |
| SECONDARY Safety and Palatability of the Study Sausage |
— | — |
Eligibility Criteria
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 ( 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
Data sourced from ClinicalTrials.gov (NCT02148835). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.