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

NCT06450808 | Active Not Recruiting

• 1 other identifier: MikroFisch
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetic Parameters

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (4)

• Acceptance index of the pesto

  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

  4 times (at the Screening, At the study period 1, at the study period 2 and 3)

• Omega-3/ Omega-6 ratio

  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

  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

Study Arms (3)

Pesto with 3% Phaeodactylum

EXPERIMENTAL

Dried Microalgae integrated in the Pesto

Dietary Supplement: Dried Microalgae biomass

Pesto with 4% Phaeodactylum

EXPERIMENTAL

Dried Microalgae integrated in the Pesto

Dietary Supplement: Dried Microalgae biomass

Pesto with 5% Phaeodactylum

EXPERIMENTAL

Dried Microalgae integrated in the Pesto

Dietary Supplement: Dried Microalgae biomass

Interventions

Dried Microalgae biomass DIETARY_SUPPLEMENT

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.

Pesto with 3% Phaeodactylum; Pesto with 4% Phaeodactylum; Pesto with 5% Phaeodactylum

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Acute illnesses or infectious diseases of any kind
• Chronic diseases that could influence the study results (investigator's decision)
• Known allergies to algae or Algae or pesto components
• smokers
• Pregnancy/breastfeeding period (anamnestic survey)
• Withdrawal of consent or lack of written consent

Sponsors & Collaborators

• University of Hohenheim: lead

Study Sites (1)

Institute of Nutritional Medicine, University of Hohenheim

Stuttgart, Baden-Wurttemberg, 70599, Germany

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Crossover: Three single-dose treatment periods
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 10, 2024
• Study Start: April 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: June 10, 2024

Record last verified: 2024-06

Locations

DE (1)