NCT04288544

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

February 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2020

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

4 months

First QC Date

February 21, 2020

Last Update Submit

October 26, 2021

Conditions

Human Nutrition, Omega-3 Fatty Acids, MicroalgaeMicronutrients

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Other Outcomes (4)

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

    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 collected before intervention after 4,8 and 12 weeks.

  • change of microbiome (stool samples)

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

  • +1 more other outcomes

Study Arms (3)

Experimental: Intervention group

ACTIVE COMPARATOR

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

Dietary Supplement: Omega-3-fatty acid capsuleDietary Supplement: sea fish

Omega-3 capsules

ACTIVE COMPARATOR

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

Dietary Supplement: MicroalgaeDietary Supplement: sea fish

sea fish (facultative)

EXPERIMENTAL

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: MicroalgaeDietary Supplement: Omega-3-fatty acid capsule

Interventions

MicroalgaeDIETARY_SUPPLEMENT

Open, monocentric intervention study in crossover design

Omega-3 capsulessea fish (facultative)
Omega-3-fatty acid capsuleDIETARY_SUPPLEMENT

Open, monocentric intervention study in crossover design

Experimental: Intervention groupsea fish (facultative)
sea fishDIETARY_SUPPLEMENT

Open, monocentric intervention study in crossover design

Experimental: Intervention groupOmega-3 capsules

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

lena Stiefvatter

Stuttgart, 70599, Germany

Location

University of Hohenheim

Stuttgart, 70599, Germany

Location

MeSH Terms

Interventions

Docosahexaenoic Acids

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 21, 2020

First Posted

February 28, 2020

Study Start

February 25, 2020

Primary Completion

June 12, 2020

Study Completion

September 15, 2020

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations

DE(2)