Health Promoting Effects of the Microalgae Phaeodactylum Tricornutum

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study Health Promoting Effects of the Microalgae Phaeodactylum Tricornutum

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

Intervention / Treatment
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* Dietary Supplement: Microalgae
* Dietary Supplement: Omega-3-fatty acid capsule
* Dietary Supplement: sea fish


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental: Intervention group<br>The patients get 1x 5,3g per day the microalgae Phaeodactylum tricornutumover for two weeks. | Dietary Supplement: Omega-3-fatty acid capsule<br>* Open, monocentric intervention study in crossover design<br>Dietary Supplement: sea fish<br>* Open, monocentric intervention study in crossover design<br>|
| Active Comparator: Omega-3 capsules<br>The patients get one capsule per day of the Omega-3-fatty acid capsules for 2 weeks. | Dietary Supplement: Microalgae<br>* Open, monocentric intervention study in crossover design<br>Dietary Supplement: sea fish<br>* Open, monocentric intervention study in crossover design<br>|
| Experimental: sea fish (facultative)<br>as positive control, one portion of fish is eaten per week for 2 weeks after the Intervention of 8 weeks and 2 wash out (omega 3 must not be eaten). | Dietary Supplement: Microalgae<br>* Open, monocentric intervention study in crossover design<br>Dietary Supplement: Omega-3-fatty acid capsule<br>* Open, monocentric intervention study in crossover design<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of concentration of omega-3 fatty acids in blood plasma | concentration of fatty acids from plasma by direct transesterification and subsequent measurement on gas chromatography. | Study examinations are before intervention, after 2,3,4,6,7,8, 10,11 and 12 weeks. | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eicosapentaenoic acid, Nutrition, micronutrients, anti-inflammatory foods, omega-3 fatty acids, microalgae