"Health Promoting Effects of the Microalgae Phaeodactylum Tricornutum"

NCT ID: NCT04288544

Last Updated: 2021-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-25

Study Completion Date

2020-09-15

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.

Conditions

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Human Nutrition, Omega-3 Fatty Acids, Microalgae Micronutrients

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental: Intervention group

The patients get 1x 5,3g per day the microalgae Phaeodactylum tricornutumover for two weeks.

Group Type ACTIVE_COMPARATOR

Omega-3-fatty acid capsule

Intervention Type DIETARY_SUPPLEMENT

Open, monocentric intervention study in crossover design

sea fish

Intervention Type DIETARY_SUPPLEMENT

Open, monocentric intervention study in crossover design

Omega-3 capsules

The patients get one capsule per day of the Omega-3-fatty acid capsules for 2 weeks.

Group Type ACTIVE_COMPARATOR

Microalgae

Intervention Type DIETARY_SUPPLEMENT

Open, monocentric intervention study in crossover design

sea fish

Intervention Type DIETARY_SUPPLEMENT

Open, monocentric intervention study in crossover design

sea fish (facultative)

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).

Group Type EXPERIMENTAL

Microalgae

Intervention Type DIETARY_SUPPLEMENT

Open, monocentric intervention study in crossover design

Omega-3-fatty acid capsule

Intervention Type DIETARY_SUPPLEMENT

Open, monocentric intervention study in crossover design

Interventions

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Microalgae

Open, monocentric intervention study in crossover design

Intervention Type DIETARY_SUPPLEMENT

Omega-3-fatty acid capsule

Open, monocentric intervention study in crossover design

Intervention Type DIETARY_SUPPLEMENT

sea fish

Open, monocentric intervention study in crossover design

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Hohenheim

OTHER

Sponsor Role lead

Responsible Party

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Stephan C. Bischoff, MD, Professor

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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lena Stiefvatter

Stuttgart, , Germany

Site Status

University of Hohenheim

Stuttgart, , Germany

Site Status

Countries

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Germany

Other Identifiers

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UHohenheim

Identifier Type: -

Identifier Source: org_study_id