"Health Promoting Effects of the Microalgae Phaeodactylum Tricornutum"

Not Applicable

Completed

• Conditions: Human Nutrition, Omega-3 Fatty Acids, Microalgae; Micronutrients
• Interventions: Dietary Supplement: Microalgae; Dietary Supplement: Omega-3-fatty acid capsule; Dietary Supplement: sea fish

• Registration Number: NCT04288544
• Lead Sponsor: University of Hohenheim

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.

Study Timeline

• Study First Submitted: 2020-02-21
• Study Start: 2020-02-25
• Study First Submitted QC: 2020-02-25
• Study First Posted: 2020-02-28
• Primary Completion: 2020-06-12
• Study Completion: 2020-09-15
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-26
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
sea fish (facultative)	Microalgae	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).
Experimental: Intervention group	Omega-3-fatty acid capsule	The patients get 1x 5,3g per day the microalgae Phaeodactylum tricornutumover for two weeks.
Experimental: Intervention group	sea fish	The patients get 1x 5,3g per day the microalgae Phaeodactylum tricornutumover for two weeks.
Omega-3 capsules	Microalgae	The patients get one capsule per day of the Omega-3-fatty acid capsules for 2 weeks.
Omega-3 capsules	sea fish	The patients get one capsule per day of the Omega-3-fatty acid capsules for 2 weeks.
sea fish (facultative)	Omega-3-fatty acid capsule	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).

Primary Outcome Measures

Name	Time	Method
change of concentration of omega-3 fatty acids in blood plasma	Study 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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

lena Stiefvatter; 🇩🇪 Stuttgart, Germany

University of Hohenheim; 🇩🇪 Stuttgart, Germany