"Health Promoting Effects of the Microalgae Phaeodactylum Tricornutum"

Micronutrients Clinical Trial

— UniHoh-Algen  

Official title:

Pilot Study "Health Promoting Effects of the Microalgae Phaeodactylum Tricornutum"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04288544
• Other study ID #: UHohenheim
• Status: Completed
• Phase: N/A
• Start date: February 25, 2020
• Est. completion date: September 15, 2020

Study information

• Verified date: October 2021
• Source: University of Hohenheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 15, 2020
• Est. primary completion date: June 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Microalgae
Open, monocentric intervention study in crossover design
• Omega-3-fatty acid capsule
Open, monocentric intervention study in crossover design
• sea fish
Open, monocentric intervention study in crossover design

Locations

Country	Name	City	State
Germany	lena Stiefvatter	Stuttgart
Germany	University of Hohenheim	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
University of Hohenheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change of Inflammation markers in the blood (c-reactive protein (crp)	determination of inflammation markers in serum	Study examinations are before intervention, after 2,3,4,6,7,8, 10,11 and 12 weeks.
Other	change of short-chain fatty acids in stool parameters	stool samples are analysed by gas chromatography (short-chain fatty acids)	Stool samples are collected before intervention after 4,8 and 12 weeks.
Other	change of microbiome (stool samples)	quantitative Analyse with Next-Generation Sequencing.	Stool samples are collected before intervention after 4,8 and 12 weeks.
Other	change of Inflammation markers in the blood like IL-6, IL-1ß	determination of inflammation markers in plasma with ELISA	study examinations are before intervention, after 2,3,4,6,7,8, 10,11 and 12 weeks.
Primary	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	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.