"Health Promoting Effects of the Microalgae Phaeodactylum Tricornutum" (UniHoh-Algen)

Pilot Study "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

Study Overview

• Status: Completed
• Conditions: Micronutrients; Human Nutrition, Omega-3 Fatty Acids, Microalgae
• Intervention / Treatment: Dietary supplement: Omega-3-fatty acid capsule; Dietary supplement: sea fish; Dietary supplement: Microalgae

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Stuttgart, Germany, 70599
    • University of Hohenheim
  • Stuttgart, Germany, 70599
    • lena Stiefvatter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Experimental: Intervention group; The patients get 1x 5,3g per day the microalgae Phaeodactylum tricornutumover for two weeks.	Dietary supplement: Omega-3-fatty acid capsule; Open, monocentric intervention study in crossover design; Dietary supplement: sea fish; Open, monocentric intervention study in crossover design
ACTIVE_COMPARATOR: Omega-3 capsules; The patients get one capsule per day of the Omega-3-fatty acid capsules for 2 weeks.	Dietary supplement: sea fish; Open, monocentric intervention study in crossover design; Dietary supplement: Microalgae; Open, monocentric intervention study in crossover design
EXPERIMENTAL: 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).	Dietary supplement: Omega-3-fatty acid capsule; Open, monocentric intervention study in crossover design; Dietary supplement: Microalgae; Open, monocentric intervention study in crossover design

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
change of microbiome (stool samples)	quantitative Analyse with Next-Generation Sequencing.	Stool samples are collected before intervention after 4,8 and 12 weeks.
change of Inflammation markers in the blood like IL-6, IL-1β	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.

Collaborators and Investigators

• Sponsor: University of Hohenheim

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 25, 2020
• Primary Completion (ACTUAL): June 12, 2020
• Study Completion (ACTUAL): September 15, 2020

Study Registration Dates

• First Submitted: February 21, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (ACTUAL): February 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: eicosapentaenoic acid, Nutrition, micronutrients, anti-inflammatory foods, omega-3 fatty acids, microalgae
• Other Study ID Numbers: UHohenheim

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No