Clinical trial NCT06450808: The Microalga Phaeodactylum Tricornutum a Potential Fish Substitute?- Pharmacokinetic Study
Official title: Die Mikroalge Phaeodactylum Tricornutum Ein Potentieller Fischersatz?- Pharmakokinetische Studie
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pharmacokinetic Parameters
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study is a prospective blinded intervention study in a cross-over design with three single-dose treatment periods (2 %, 3 % and 4 % PT content in the investigational product) and a 14-day washout phase between the treatment periods.
Primary purpose: TREATMENT

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 volunteers/patients 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.

Eligibility criteria: Inclusion Criteria:

* Good general condition (investigator's decision)
* Declaration of consent for participation in the study

Exclusion Criteria:

* Acute illnesses or infectious diseases of any kind
* Chronic diseases that could influence the study results (investigator's decision)
* Chronic intestinal diseases and gastritis are exclusion criteria other than than CHD / COPD / neuromuscular diseases
* Known allergies to algae or Algae or pesto components
* smokers
* Pregnancy/breastfeeding period (anamnestic survey)
* Withdrawal of consent or lack of written consent

Primary outcomes:
measure: Area under the curve (AUC)- Eicosapentaonic acid
timeFrame: zero to 48 hours, during the whole study
measure: Area under the curve (AUC)- Fucoxanthin
timeFrame: zero to 48 hours, during the whole study
measure: Area under the curve (AUC)- B-Carotin
timeFrame: zero to 48 hours, during the whole study
measure: Maximum Plasma Concentration [Cmax] of Eicosapentaonic acid
timeFrame: zero to 48 hours, during the whole study
measure: Maximum Plasma Concentration [Cmax] of Fucoxanthin
timeFrame: zero to 48 hours, during the whole study
measure: Maximum Plasma Concentration [Cmax] of B-Carotin
timeFrame: zero to 48 hours, during the whole study
measure: Time of the maximum measured plasma concentration (max) of Eicosapentaonic acid
timeFrame: zero to 48 hours, during the whole study
measure: Time of the maximum measured plasma concentration (max) of Fucoxanthin
timeFrame: zero to 48 hours, during the whole study
measure: Time of the maximum measured plasma concentration (max) of B--Carotin
timeFrame: zero to 48 hours, during the whole study
Secondary outcomes:
measure: Acceptance index of the pesto
timeFrame: 3 times of each pesto dose were Testet (the Microalgae is added zu 3%, 4% and 5% to the Pesto)
measure: Diagnostic markers in the blood
timeFrame: 4 times (at the Screening, At the study period 1, at the study period 2 and 3)
measure: Omega-3/ Omega-6 ratio
timeFrame: 28 times (at the Screening, At the study period 1 (9 x), at the study period 2 (9x) and period 3 (9x), One period means before eating the pesto Timepoint 0, after 1h, after 2h, 4h, 6h,8h,10h,24h,48h
measure: Evaluation of the food diary, MEDAS questionnaire, FFQ questionnaire
timeFrame: the food diary is kept 3 x during the 3-day study, the MEDAS and FFQ are filled out once at the beginning of the study
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Institute of Nutritional Medicine, University of Hohenheim
state: Baden-Württemberg
Study officials:
References: