NCT05120791

Brief Summary

Investigation of the microalgae Phaeodactylum as food with regard to the uptake of omega-3 fatty acids and effects on various blood parameters in relation to age. Bioavailability and excretion of nutrients and their effects on fatty acid status and inflammatory markers.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

July 6, 2022

Status Verified

July 1, 2022

Enrollment Period

Same day

First QC Date

October 26, 2021

Last Update Submit

July 4, 2022

Conditions

AgingWell Aging

Keywords

Microalgaeomega-3 fatty acidsMicronutrientscarotinoidsInflammation

Outcome Measures

Primary Outcomes (1)

  • Change in omega-6/omega-3 ratio (plasma level basis)

    fatty acid chromatographic measurement

    14 days

Secondary Outcomes (3)

  • Omega-3 fatty acid index

    14 days

  • Uptake of fucoxanthin and beta-carotene

    14 days

  • Inflammation (CRP)

    14 days

Other Outcomes (4)

  • Markers for oxidative stress

    14 days

  • Albumin

    14 days

  • weight

    14 days

  • +1 more other outcomes

Study Arms (4)

Placebo

PLACEBO COMPARATOR

14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1,3g)

Dietary Supplement: Placebo vegetable bouillon

Microalgae phaeodactylum

ACTIVE COMPARATOR

14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1.3g), 2.3g Microalgae Phaeodactylum

Dietary Supplement: microalgae phaeodactylum

Beta-Glucan

ACTIVE COMPARATOR

14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1.3g), Beta-Glucan (1.8g)

Dietary Supplement: From the Microalgae phaeodactylum the extracted beta-Glucan (especially chrysolaminarin)

Combi Microalgae phaeodacytlum and Beta-Glucan

ACTIVE COMPARATOR

14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1.3g), 2.3g Microalgae, Beta-Glucan (1.8g)

Dietary Supplement: A combination of the vegetable bouillon, the microalgae and the beta-Glucan

Interventions

Placebo vegetable bouillonDIETARY_SUPPLEMENT

14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1,3g)

Placebo
microalgae phaeodactylumDIETARY_SUPPLEMENT

14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1.3g), 2.3g Microalgae Phaeodactylum

Microalgae phaeodactylum
From the Microalgae phaeodactylum the extracted beta-Glucan (especially chrysolaminarin)DIETARY_SUPPLEMENT

14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1.3g), Beta-Glucan (1.8g)

Beta-Glucan
A combination of the vegetable bouillon, the microalgae and the beta-GlucanDIETARY_SUPPLEMENT

14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1.3g), 2.3g Microalgae, Beta-Glucan (1.8g)

Combi Microalgae phaeodacytlum and Beta-Glucan

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age ≥60 ≤90 years, weight ≥50 kg, generally healthy
  • Signed informed consent form
  • Willingness to follow the prescribed diet for the duration of the study
  • No participation in any other clinical trial (current or within the last 30 days)

You may not qualify if:

  • Taking intestinal therapeutics, antibiotics, immunosuppressants or similar. (if necessary, decision on a case-by-case basis)
  • Pregnancy/breastfeeding
  • Relevant violations of the dietary protocol
  • Occurrence of relevant diseases (if necessary, individual case decision)
  • Withdrawal of consent
  • Placement in a clinic or similar facility due to official or court order

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stephan C. Bischoff, Prof. Dr

Stuttgart, Baden-Wurttemberg, Germany

RECRUITING

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Stephan C Bischoff, Prof. Dr

CONTACT

0711 459 24101bischoff.stephan@uni-hohenheim.de

Lena Stiefvatter, M.SC

CONTACT

071145924881lena.stiefvatter@uni-hohenheim.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 4 arm parallel groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 26, 2021

First Posted

November 15, 2021

Study Start

July 1, 2022

Primary Completion

July 1, 2022

Study Completion

August 1, 2022

Last Updated

July 6, 2022

Record last verified: 2022-07

Locations

DE(1)