NCT05650294

Brief Summary

The goal of this clinical trial is to compare the uptake of two different omega-3 fatty acid preparations in healthy adults. The main question it aims to answer is whether the two different preparations have the same uptake after single dose supplementation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

November 24, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 14, 2022

Completed
26 days until next milestone

Study Start

First participant enrolled

January 9, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2023

Completed
Last Updated

March 2, 2023

Status Verified

March 1, 2023

Enrollment Period

1 month

First QC Date

November 24, 2022

Last Update Submit

March 1, 2023

Conditions

AbsorptionPharmacokinetics

Keywords

Omega 3 fatty acidsEPADHA

Outcome Measures

Primary Outcomes (1)

  • Comparison of iAUC of EPA+DHA from 0 to 12 hours (iAUC0-12h) between two study products

    Blood concentrations of EPA + DHA in plasma at 0h and 12h will be analyzed, and determination of iAUC0-12h will be calculated. After getting the iAUC0-12h, difference of AUC curves between groups will be calculated. The time point 0h is defined as the time when study subjects is taking the supplement, while time point 12h is defined as 12 hours after the intake of supplement.

    0h-12h (on Day 1 and Day 15)

Secondary Outcomes (17)

  • Comparison of iAUC of EPA+DHA from 0 to 24hours (iAUC0-24h) between two study products

    0h-24h (on Day 2 and Day 16)

  • Comparison of iAUC EPA+DHA from 0 to 72hours (iAUC0-72h) between two study products

    0h-72h (on Day 4 and Day 18)

  • Comparison of iAUC EPA from 0 to 12hours (iAUC0-12h) between two study products

    0h-12h (on Day 1 and Day 15)

  • Comparison of iAUC DHA from 0 to 12hours (iAUC0-12h) between two study products

    0h-12h (on Day 1 and Day 15)

  • Comparison of iAUC EPA from 0 to 24hours (iAUC0-24h) between two study products

    0h-24h (on Day 2 and Day 16)

  • +12 more secondary outcomes

Other Outcomes (2)

  • Number of participants with treatment-related adverse events (AE) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0

    Day 1 to Day 3 and Day 15 to Day 18

  • Number of participants with abnormal blood routine parameters as assessed by clinical reference values

    Day 1 and Day 15

Study Arms (2)

Active group

ACTIVE COMPARATOR

This group will receive a single dose of the PL+ omega 3 fatty acids capsules first, then receive a single dose of the standard FO EE omega 3 fatty acids capsules. Wash-out period is 2 weeks between treatments.

Dietary Supplement: PL+ omega 3 fatty acidsDietary Supplement: FO EE fatty acids

Placebo group

PLACEBO COMPARATOR

This group will receive a single dose of the standard FO EE omega 3 fatty acids capsules first, then receive a single dose of the PL+ omega 3 fatty acids capsules. Wash-out period is 2 weeks between treatments.

Dietary Supplement: PL+ omega 3 fatty acidsDietary Supplement: FO EE fatty acids

Interventions

PL+ omega 3 fatty acidsDIETARY_SUPPLEMENT

PL+ omega 3 fatty acids is a food supplement that combines krill oil and FO EE. The dose will be around 1250 mg EPA+DHA.

Active groupPlacebo group
FO EE fatty acidsDIETARY_SUPPLEMENT

A conventional fish oil food supplement containing EPA and DHA in the EE form. The dose will be 1250 mg EPA+DHA.

Active groupPlacebo group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy males or females (1:1) aged 18 - 65 years
  • Capable and willing to give written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
  • Have a low habitual consumption of fatty fish and seafood, defined as a frequency of twice per month or less
  • No fish consumption at least two weeks prior to screening visit
  • Omega-3 index (≤ 7 %)
  • Non-smoker
  • BMI: 18 to 32 kg/m2

You may not qualify if:

  • Omega-3 supplementation history within the last 4 weeks
  • Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases, i.e., diabetes, cardiovascular, pulmonary, hematologic, gastrointestinal, neurological, or infectious diseases which could confound the results of the study or put the subject at undue risk
  • Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 365 days prior to baseline
  • Pregnancy, breast feeding or intention to become pregnant during the study (a pregnancy test will be conducted during screening and visits 1-2)
  • Haemoglobin: \< 12.0 g/dL (women); \< 13.5 g/dL (men)
  • Platelets: \< 150 x 103/μL
  • Leukocytes \< 4,4 x 103/mm3
  • Aspartate transaminase (AST) or alanine transaminase (ALT) within the normal range
  • Serum creatine within the normal range
  • or further for this study clinically relevant abnormal laboratory findings at screening
  • Significant changes in lifestyle or medication (within last 2 months)
  • Chronic intake of substances affecting blood coagulation (e.g. acetylic acid, anticoagulants (e.g. Marcumar), diuretics, thiazides), which in the investigator's opinion would impact subject safety
  • Difficulty swallowing capsules or predicted inability to swallow the study products
  • Individuals who have made a blood donation in excess of 500 mL or who had excess blood loss within the 4 months before the study starts
  • Individuals who are currently enrolled in an ongoing clinical trial or who have been an active participant in a clinical trial within the last 4 weeks
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BioTeSys GmbH

Esslingen am Neckar, Germany

Location

Study Officials

  • Daniel Menzel

    BioTeSys GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The clinical study will be performed unblinded. However, analysis of blood samples at analysis partner will be performed blinded. After closure of data base, data will be unblinded and evaluated according to product affiliation.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: randomized, two-way cross-over study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2022

First Posted

December 14, 2022

Study Start

January 9, 2023

Primary Completion

February 17, 2023

Study Completion

February 17, 2023

Last Updated

March 2, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Data will not be shared

Locations

DE(1)