Healthy Volunteers Clinical Trial
Official title:
Influence of Dietary Omega-3 Fatty Acids in Various triOMEG Sausages on the HS-Omega-3 Index in Healthy Individuals
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.
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.
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