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Completed

NCT Number: NCT04288544

"Health Promoting Effects of the Microalgae Phaeodactylum Tricornutum"

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

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Key information

Conditions

Human Nutrition, Omega-3 Fatty Acids, Microalgae Micronutrients

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Hohenheim, Stuttgart, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microalgae

Dietary Supplement

Open, monocentric intervention study in crossover design

Omega-3-fatty acid capsule

Dietary Supplement

Open, monocentric intervention study in crossover design

sea fish

Dietary Supplement

Open, monocentric intervention study in crossover design

Primary outcomes

  1. change of concentration of omega-3 fatty acids in blood plasma

    Time frame: 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 outcomes

  1. change of concentration of amino acids and carotenoids (fucoxanthin)

    Time frame: 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 outcomes

  1. change of Inflammation markers in the blood (c-reactive protein (crp)

    Time frame: Study examinations are before intervention, after 2,3,4,6,7,8, 10,11 and 12 weeks.

    determination of inflammation markers in serum

  2. change of short-chain fatty acids in stool parameters

    Time frame: Stool samples are collected before intervention after 4,8 and 12 weeks.

    stool samples are analysed by gas chromatography (short-chain fatty acids)

  3. change of microbiome (stool samples)

    Time frame: Stool samples are collected before intervention after 4,8 and 12 weeks.

    quantitative Analyse with Next-Generation Sequencing.

  4. change of Inflammation markers in the blood like IL-6, IL-1β

    Time frame: study examinations are before intervention, after 2,3,4,6,7,8, 10,11 and 12 weeks.

    determination of inflammation markers in plasma with ELISA

Sponsors and collaborators

Lead sponsor

University of Hohenheim

Other

Registry information

Official study title

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

Acronym: UniHoh-Algen

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 28, 2020
Registry last updated
Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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