Pharmacokinetic ParametersMikroFischNCT06450808
The Microalga Phaeodactylum Tricornutum a Potential Fish Substitute?- Pharmacokinetic Study
A study testing Dried Microalgae biomass in people with Pharmacokinetic Parameters, run by University of Hohenheim at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetic Parameters
- What is being tested?
- Dried Microalgae biomass
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2024to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good general condition (investigator's decision)
- Declaration of consent for participation in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Nutritional Medicine, University of Hohenheim
Stuttgart, Baden-Wurttemberg, 70599
About this study
Official title: 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.
Read the 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.
- Conditions
- Pharmacokinetic Parameters
- Being tested
- Dried Microalgae biomass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dried Microalgae biomassDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Pesto with 3% Phaeodactylum | Experimental | Dried Microalgae integrated in the Pesto Receives: Dietary Supplement: Dried Microalgae biomass |
| Pesto with 4% Phaeodactylum | Experimental | Dried Microalgae integrated in the Pesto Receives: Dietary Supplement: Dried Microalgae biomass |
| Pesto with 5% Phaeodactylum | Experimental | Dried Microalgae integrated in the Pesto Receives: Dietary Supplement: Dried Microalgae biomass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC)- Eicosapentaonic acid
pharmacokinetic parameters measured in blood plasma
Measured: zero to 48 hours, during the whole study
Area under the curve (AUC)- Fucoxanthin
pharmacokinetic parameters measured in blood plasma
Measured: zero to 48 hours, during the whole study
Area under the curve (AUC)- B-Carotin
pharmacokinetic parameters measured in blood plasma
Measured: zero to 48 hours, during the whole study
Maximum Plasma Concentration [Cmax] of Eicosapentaonic acid
pharmacokinetic parameters measured in blood plasma
Measured: zero to 48 hours, during the whole study
Maximum Plasma Concentration [Cmax] of Fucoxanthin
pharmacokinetic parameters measured in blood plasma
Measured: zero to 48 hours, during the whole study
Maximum Plasma Concentration [Cmax] of B-Carotin
pharmacokinetic parameters measured in blood plasma
Measured: 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
Measured: zero to 48 hours, during the whole study
Time of the maximum measured plasma concentration (max) of Fucoxanthin
pharmacokinetic parameters measured in blood plasma
Measured: 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
Measured: zero to 48 hours, during the whole study
Secondary outcomes (4)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 Apr 2024
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetic ParametersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450808
- Sponsor's protocol ID
- MikroFisch
- Acronym
- MikroFisch
- Status last verified
- Jun 2024
- First submitted
- 27 May 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Die Mikroalge Phaeodactylum Tricornutum Ein Potentieller Fischersatz?- Pharmakokinetische Studie
- ClinicalTrials.gov ID
- NCT06450808
- Acronym / sponsor ID
- MikroFisch / MikroFisch
- Conditions
- Pharmacokinetic Parameters
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pesto with 3% Phaeodactylum | Experimental | Dietary Supplement: Dried Microalgae biomassDried Microalgae integrated in the Pesto |
| Pesto with 4% Phaeodactylum | Experimental | Dietary Supplement: Dried Microalgae biomassDried Microalgae integrated in the Pesto |
| Pesto with 5% Phaeodactylum | Experimental | Dietary Supplement: Dried Microalgae biomassDried Microalgae integrated in the Pesto |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Good general condition (investigator's decision)
- Declaration of consent for participation in the study
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dried Microalgae biomassThe 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. | Dietary supplement | Pesto with 3% Phaeodactylum, Pesto with 4% Phaeodactylum, Pesto with 5% Phaeodactylum |
Primary outcome
Area under the curve (AUC)- Eicosapentaonic acid
Time frame: zero to 48 hours, during the whole study
pharmacokinetic parameters measured in blood plasma
Area under the curve (AUC)- Fucoxanthin
Time frame: zero to 48 hours, during the whole study
pharmacokinetic parameters measured in blood plasma
Area under the curve (AUC)- B-Carotin
Time frame: zero to 48 hours, during the whole study
pharmacokinetic parameters measured in blood plasma
Maximum Plasma Concentration [Cmax] of Eicosapentaonic acid
Time frame: zero to 48 hours, during the whole study
pharmacokinetic parameters measured in blood plasma
Maximum Plasma Concentration [Cmax] of Fucoxanthin
Time frame: zero to 48 hours, during the whole study
pharmacokinetic parameters measured in blood plasma
Maximum Plasma Concentration [Cmax] of B-Carotin
Time frame: zero to 48 hours, during the whole study
pharmacokinetic parameters measured in blood plasma
Time of the maximum measured plasma concentration (max) of Eicosapentaonic acid
Time frame: zero to 48 hours, during the whole study
pharmacokinetic parameters measured in blood plasma
Time of the maximum measured plasma concentration (max) of Fucoxanthin
Time frame: zero to 48 hours, during the whole study
pharmacokinetic parameters measured in blood plasma
Time of the maximum measured plasma concentration (max) of B--Carotin
Time frame: zero to 48 hours, during the whole study
pharmacokinetic parameters measured in blood plasma
4 secondary outcomes
Acceptance index of the pesto
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
Time frame: 4 times (at the Screening, At the study period 1, at the study period 2 and 3)
Omega-3/ Omega-6 ratio
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dried Microalgae biomass in people with Pharmacokinetic Parameters, run by University of Hohenheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC)- Eicosapentaonic acid (time frame: zero to 48 hours, during the whole study). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.