Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450808
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-05-27
Brief Title:
The Microalga Phaeodactylum Tricornutum a Potential Fish Substitute- Pharmacokinetic Study
Sponsor:
University of Hohenheim
Organization:
University of Hohenheim
Study Overview
Official Title:
Die Mikroalge Phaeodactylum Tricornutum Ein Potentieller Fischersatz- Pharmakokinetische Studie
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MikroFisch
Brief Summary:
In a cross-over design pestos enriched with different levels of the microalgae Phaeodactylumtricornutum 2-3-4 will be tested The bioavailability of long-chain omega-3 fatty acids in particular EPA and carotenoids will be analysed in blood plasma postprandially within two days after a single dose Pharmacokinetic parameters will be calculated from the measured data The aim of the study is to gain insight into the bioavailability of selected microalgae constituents and the acceptance of microalgae pesto
Detailed Description:
The main objective of the project Healthy nutrition through microalgae as a fish substitute with the acronym MikroFisch is to develop a novel fish substitute product based on microalgae biomass that provides us with essential nutrients More and more people are interested in a healthy sustainable diet and are looking for plant-based alternatives These are available in a wide variety for meat but not for fish although sources of essential nutrients such as eicosapentaenoic acid and docosahexaenoic acid are urgently needed which is where our concept of evaluating microalgae as a future food comes in Based on current trends the investigators see great development potential for our approach The prerequisites for this are proof of the non-toxicity of the microalgae used sufficient absorption of the nutrients they contain in the human gut and the development of a presentation form that is suitable for food technology and sensory analysis If these requirements can be met a food product based on microalgae could enjoy a high level of acceptance The Institute of Nutritional Medicine at the University of Hohenheim has been researching the microalgae PT for several years As PT is not authorised as a novel food studies on the suitability of the microalgae as a foodstuff must be carried out The aim of the study is to characterise the pharmacokinetics of the dried microalgae Phaeodactylum tricornutum processed in a pesto investigational product in healthy volunteerspatients in order to gain insights into its absorption distribution in the organism metabolisation and excretion In particular the time courses of the plasma concentrations of eicosapentaenoic acid EPA and the carotenoids fucoxanthin and b-carotene will be analysed and the microalgae must also be properly processed into a tasty product before it can be used as food For this reason the concentration-dependent acceptance of the dosage form of the microalgae is also being analysed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None