Clinical trial NCT04288544: "Health Promoting Effects of the Microalgae Phaeodactylum Tricornutum"
Official title: Pilot Study "Health Promoting Effects of the Microalgae Phaeodactylum Tricornutum"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Nutrition, Omega-3 Fatty Acids, Microalgae
Micronutrients
Keywords: eicosapentaenoic acid, Nutrition, micronutrients, anti-inflammatory foods, omega-3 fatty acids, microalgae
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the research project is to investigate the uptake of omega-3 fatty acids into the blood plasma through the consumption of the microalgae Phaeodactylum tricornutum (PT) in a human study. In an open, crossover study, the volunteers will receive a drink enriched with the microalgae P. tricornutum or an omega-3 fatty acid preparation or (optionally) pollock for 14 days each. Since the microalgae P. tricornutum is rich in omega-3 fatty acids, the target parameter chosen is the uptake of omega-3 fatty acids in the blood plasma

Detailed description: A large number of diet-related diseases, such as obesity, are characterized by subclinical inflammation of the body. For this reason, anti-inflammatory foods such as omega-3 fatty acids, which are found in fish and nuts, are used. However, the disadvantage of fish as a resource is its limited availability. Therefore, it is of great interest to provide a resource-saving diet that still supplies us with all macro and micro nutrients. For this reason, microalgae have become the focus of science in recent years. Microalgae not only serve as a source of protein, but also contain a large number of nutrients that could have possible physiological and preventive effects in human nutrition. These include substances from the group of carotenoids and the various polyunsaturated FS found in microalgae.

The microalgae PT is rich in omega-3 FS eicosapentaenoic acid (EPA), which is otherwise found mainly in fatty fish, and could therefore be an alternative or vegetarian source of polyunsaturated fatty acids.

Previous work by U. Neumann has shown that the microalgae P. tricornutum could be used for human nutrition. No toxic effects could be observed in vivo and the bioavailability of fatty acids and proteins could also be successfully demonstrated. In vitro experiments also showed a more anti-inflammatory, anti-oxidative and anti-proliferative effect on human blood cells. For this reason, a health-promoting effect is also possible in human nutrition, but this must be proven in human studies.

Eligibility criteria: Inclusion Criteria:

* Signed declaration of consent
* Willingness to follow the prescribed diet for the duration of the study
* No participation in another clinical trial (current or within the last 30 days)

Exclusion Criteria:

* Taking intestinal therapeutics, antibiotics, immunosuppressive drugs or similar (if necessary, individual case decision)
* Pregnancy/nursing period
* Relevant violations of the food protocol
* Occurrence of relevant diseases (if necessary, individual case decision)
* Revocation of consent
* Accommodation in a clinic or similar institution due to official or court order

Primary outcomes:
measure: change of concentration of omega-3 fatty acids in blood plasma
timeFrame: Study examinations are before intervention, after 2,3,4,6,7,8, 10,11 and 12 weeks.
Secondary outcomes:
measure: change of concentration of amino acids and carotenoids (fucoxanthin)
timeFrame: Study examinations are before intervention, after 2,3,4,6,7,8, 10,11 and 12 weeks.
Other outcomes:
measure: change of Inflammation markers in the blood (c-reactive protein (crp)
timeFrame: Study examinations are before intervention, after 2,3,4,6,7,8, 10,11 and 12 weeks.
measure: change of short-chain fatty acids in stool parameters
timeFrame: Stool samples are collected before intervention after 4,8 and 12 weeks.
measure: change of microbiome (stool samples)
timeFrame: Stool samples are collected before intervention after 4,8 and 12 weeks.
measure: change of Inflammation markers in the blood like IL-6, IL-1β
timeFrame: study examinations are before intervention, after 2,3,4,6,7,8, 10,11 and 12 weeks.
Locations:
city: Stuttgart
country: Germany
facility: lena Stiefvatter
city: Stuttgart
country: Germany
facility: University of Hohenheim
Study officials:
References: