The Microalga Phaeodactylum Tricornutum a Potential Fish Substitute?- Pharmacokinetic Study (MikroFisch)

Die Mikroalge Phaeodactylum Tricornutum Ein Potentieller Fischersatz?- Pharmakokinetische Studie

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pharmacokinetic Parameters
• Intervention / Treatment: Dietary supplement: Dried Microalgae biomass

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Stuttgart, Baden-Württemberg, Germany, 70599
      • Institute of Nutritional Medicine, University of Hohenheim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pesto with 3% Phaeodactylum; 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.
Experimental: Pesto with 4% Phaeodactylum; 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.
Experimental: Pesto with 5% Phaeodactylum; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the curve (AUC)- Eicosapentaonic acid	pharmacokinetic parameters measured in blood plasma	zero to 48 hours, during the whole study
Area under the curve (AUC)- Fucoxanthin	pharmacokinetic parameters measured in blood plasma	zero to 48 hours, during the whole study
Area under the curve (AUC)- B-Carotin	pharmacokinetic parameters measured in blood plasma	zero to 48 hours, during the whole study
Maximum Plasma Concentration [Cmax] of Eicosapentaonic acid	pharmacokinetic parameters measured in blood plasma	zero to 48 hours, during the whole study
Maximum Plasma Concentration [Cmax] of Fucoxanthin	pharmacokinetic parameters measured in blood plasma	zero to 48 hours, during the whole study
Maximum Plasma Concentration [Cmax] of B-Carotin	pharmacokinetic parameters measured in blood plasma	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	zero to 48 hours, during the whole study
Time of the maximum measured plasma concentration (max) of Fucoxanthin	pharmacokinetic parameters measured in blood plasma	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	zero to 48 hours, during the whole study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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	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

Collaborators and Investigators

• Sponsor: University of Hohenheim

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: May 27, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MikroFisch

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No