Uptake of an Omega-3 Oil in Healthy Adults

NCT ID: NCT05650294

Last Updated: 2023-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2023-02-17

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.

Detailed Description

Participants will be asked to take capsules of the new "phospholipids+" (PL+) omega-3 product (a combination product of krill oil and fish oil) in the morning with a low-fat breakfast. This product contains around 1250 mg eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA).

Researchers will compare this group with another group that takes standard fish oil (FO) ethyl esters (EE, with the same amount of EPA+DHA) to see if there are differences in pharmacokinetic parameters, including incremental area under the curve (iAUC), the maximum concentration of (Cmax) and the time it takes for EPA, DHA and EPA+DHA to reach the maximum concentration (Tmax) in plasma.

Conditions

Absorption; Pharmacokinetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Active group

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.

Group Type: ACTIVE_COMPARATOR

PL+ omega 3 fatty acids

Intervention Type: DIETARY_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.

FO EE fatty acids

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo group

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.

Group Type: PLACEBO_COMPARATOR

PL+ omega 3 fatty acids

Intervention Type: DIETARY_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.

FO EE fatty acids

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

PL+ omega 3 fatty acids

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.

Intervention Type: DIETARY_SUPPLEMENT

FO EE fatty acids

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• A known allergy or hypersensitivity to any of the ingredients of the study products
• Not willing to abstain from fish consumption or foods/oils high in omega-3 fatty acids
• Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BioTeSys GmbH

OTHER

Sponsor Role: collaborator

Aker BioMarine Human Ingredients AS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Menzel

Role: PRINCIPAL_INVESTIGATOR

BioTeSys GmbH

Locations

BioTeSys GmbH

Esslingen am Neckar, , Germany

Countries

Germany

Other Identifiers

BTS1879/22 // AKBM188H

Identifier Type: -

Identifier Source: org_study_id