An interventional study of Dried Microalgae biomass in Pharmacokinetic Parameters, sponsored by University of Hohenheim. Active, not recruiting at 1 site in Germany. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-10.
Sponsored by University of Hohenheim · Not applicable, Interventional, and Treatment
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.
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.
University of Hohenheim is the lead sponsor of 43 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dried Microalgae integrated in the Pesto
Dietary Supplement: Dried Microalgae biomass
Dried Microalgae integrated in the Pesto
Dietary Supplement: Dried Microalgae biomass
Dried Microalgae integrated in the Pesto
Dietary Supplement: Dried Microalgae biomass
The products to be tested are pestos enriched with different amounts of the microalgae Phaeodactylum tricornutum (3, 4 and 5%). After drying, the microalgae Phaeodactylum, which has already been used in two previous applications (application german ethic F-2020-001), is added to the pesto. Three different pestos will be produced and enriched with different amounts of the microalgae Phaeodactylum.
Area under the curve (AUC)- Eicosapentaonic acid
pharmacokinetic parameters measured in blood plasma
Time frame: zero to 48 hours, during the whole study
Area under the curve (AUC)- Fucoxanthin
pharmacokinetic parameters measured in blood plasma
Time frame: zero to 48 hours, during the whole study
Area under the curve (AUC)- B-Carotin
pharmacokinetic parameters measured in blood plasma
Time frame: zero to 48 hours, during the whole study
Maximum Plasma Concentration [Cmax] of Eicosapentaonic acid
pharmacokinetic parameters measured in blood plasma
Time frame: zero to 48 hours, during the whole study
Maximum Plasma Concentration [Cmax] of Fucoxanthin
pharmacokinetic parameters measured in blood plasma
Time frame: zero to 48 hours, during the whole study
Maximum Plasma Concentration [Cmax] of B-Carotin
pharmacokinetic parameters measured in blood plasma
Time frame: zero to 48 hours, during the whole study
Time of the maximum measured plasma concentration (max) of Eicosapentaonic acid
pharmacokinetic parameters measured in blood plasma
Time frame: zero to 48 hours, during the whole study
Time of the maximum measured plasma concentration (max) of Fucoxanthin
pharmacokinetic parameters measured in blood plasma
Time frame: zero to 48 hours, during the whole study
Time of the maximum measured plasma concentration (max) of B--Carotin
pharmacokinetic parameters measured in blood plasma
Time frame: zero to 48 hours, during the whole study
Acceptance index of the pesto
A scale of 1 to 9 was used in this tasting study, labelled: 1=I don't like it at all; 5=neither; 9=I really like it. The categories to be evaluated were colour, smell, taste, texture and general acceptability.
Time frame: 3 times of each pesto dose were Testet (the Microalgae is added zu 3%, 4% and 5% to the Pesto)
Diagnostic markers in the blood
Laboratory parameters
Time frame: 4 times (at the Screening, At the study period 1, at the study period 2 and 3)
Omega-3/ Omega-6 ratio
in plasma measurement
Time frame: 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
Evaluation of the food diary, MEDAS questionnaire, FFQ questionnaire
questionnaire to document food intake
Time frame: 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
Plan to share: Undecided
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This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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University of Hohenheim