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Health Promoting Effects of the Microalgae Phaeodactylum Tricornutum

Pilot Study Health Promoting Effects of the Microalgae Phaeodactylum Tricornutum

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04288544
Acronym
UniHoh-Algen
Enrollment
20
Registered
2020-02-28
Start date
2020-02-25
Completion date
2020-09-15
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Nutrition, Omega-3 Fatty Acids, Microalgae, Micronutrients

Keywords

eicosapentaenoic acid, Nutrition, micronutrients, anti-inflammatory foods, omega-3 fatty acids, microalgae

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.

Interventions

DIETARY_SUPPLEMENTMicroalgae

Open, monocentric intervention study in crossover design

DIETARY_SUPPLEMENTOmega-3-fatty acid capsule

Open, monocentric intervention study in crossover design

DIETARY_SUPPLEMENTsea fish

Open, monocentric intervention study in crossover design

Sponsors

University of Hohenheim
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
change of concentration of omega-3 fatty acids in blood plasmaStudy examinations are before intervention, after 2,3,4,6,7,8, 10,11 and 12 weeks.concentration of fatty acids from plasma by direct transesterification and subsequent measurement on gas chromatography.

Secondary

MeasureTime frameDescription
change of concentration of amino acids and carotenoids (fucoxanthin)Study examinations are before intervention, after 2,3,4,6,7,8, 10,11 and 12 weeks.determination of amino acids from plasma by a gas chromatography determination of carotenoids from plasma by HPLC

Other

MeasureTime frameDescription
change of Inflammation markers in the blood (c-reactive protein (crp)Study examinations are before intervention, after 2,3,4,6,7,8, 10,11 and 12 weeks.determination of inflammation markers in serum
change of short-chain fatty acids in stool parametersStool samples are collected before intervention after 4,8 and 12 weeks.stool samples are analysed by gas chromatography (short-chain fatty acids)
change of microbiome (stool samples)Stool samples are collected before intervention after 4,8 and 12 weeks.quantitative Analyse with Next-Generation Sequencing.
change of Inflammation markers in the blood like IL-6, IL-1βstudy examinations are before intervention, after 2,3,4,6,7,8, 10,11 and 12 weeks.determination of inflammation markers in plasma with ELISA

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026