Uptake of an Omega-3 Oil in Healthy Adults

Not Applicable

Completed

• Conditions: Absorption; Pharmacokinetics
• Interventions: Dietary Supplement: PL+ omega 3 fatty acids; Dietary Supplement: FO EE fatty acids

• Registration Number: NCT05650294
• Lead Sponsor: Aker BioMarine Human Ingredients AS

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.

Study Timeline

• Study First Submitted: 2022-11-24
• Study First Submitted QC: 2022-12-06
• Study First Posted: 2022-12-14
• Study Start: 2023-01-09
• Primary Completion: 2023-02-17
• Study Completion: 2023-02-17
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-01
• Last Update Posted: 2023-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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)

• General Safety & Laboratory Exclusion Criteria. Patients will be excluded from the study based on the following criteria:

  • 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active group	PL+ omega 3 fatty acids	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.
Active group	FO EE fatty acids	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.
Placebo group	PL+ omega 3 fatty acids	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.
Placebo group	FO EE fatty acids	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.

Primary Outcome Measures

Name	Time	Method
Comparison of iAUC of EPA+DHA from 0 to 12 hours (iAUC0-12h) between two study products	0h-12h (on Day 1 and Day 15)	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.

Secondary Outcome Measures

Name	Time	Method
Comparison of iAUC DHA from 0 to 24hours (iAUC0-24h) between two study products	0h-24h (on Day 2 and Day 16)	Blood concentrations for DHA in plasma at 0h and 24h will be analyzed, and iAUC0-24h will be calculated. After getting the iAUC0-24h, 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 24h is defined as 24 hours after the intake of supplement.
Comparison of iAUC DHA from 0 to 12hours (iAUC0-12h) between two study products	0h-12h (on Day 1 and Day 15)	Blood concentrations for DHA in plasma at 0h and 12h will be analyzed, and 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.
Comparison of iAUC DHA from 0 to 72hours (iAUC0-72h) between two study products	0h-72h (on Day 4 and Day 18)	Blood concentrations for DHA in plasma at 0h and 72h will be analyzed, and iAUC0-72h will be calculated. After getting the iAUC0-72h, 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 72h is defined as 72 hours after the intake of supplement.
Difference on Tmax of EPA+DHA between two products	Day 1 and Day 15	Tmax of EPA+DHA will be calculated for both products, and the difference will be compared between the products.
Difference on Tmax of DHA between two products	Day 1 and Day 15	Tmax of DHA will be calculated for both products, and the difference will be compared between the products.
Difference on total omega 6 fatty acids vs total omega 3 fatty acid ratio (n-6/n-3) in plasma at 12 hours between two products	Day 1 and Day 15	Total omega 6 fatty acids include: linoleic acid, γ-Linolenic acid, eicosadienoic acid, eicosatrienoic acid, arachidonic acid, adrenic acid, and docosapentaenoic acid. Total omega 3 fatty acids include: α-Linolenic acid, EPA, docosapentaenoate acid and DHA. The difference on n-6/n-3 ratio will be calculated between two products.; The time point 12h is defined as 12 hours after the intake of supplement.
Comparison of iAUC of EPA+DHA from 0 to 24hours (iAUC0-24h) between two study products	0h-24h (on Day 2 and Day 16)	Blood concentrations for EPA+DHA in plasma at 0h and 24h will be analyzed, and iAUC0-24h will be calculated. After getting the iAUC0-24h, 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 24h is defined as 24 hours after the intake of supplement.
Comparison of iAUC EPA+DHA from 0 to 72hours (iAUC0-72h) between two study products	0h-72h (on Day 4 and Day 18)	Blood concentrations for EPA+DHA in plasma at 0h and 72h will be analyzed, and iAUC0-72h will be calculated. After getting the iAUC0-72h, 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 72h is defined as 72 hours after the intake of supplement.
Comparison of iAUC EPA from 0 to 12hours (iAUC0-12h) between two study products	0h-12h (on Day 1 and Day 15)	Blood concentrations for EPA in plasma at 0h and 12h will be analyzed, and 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.
Comparison of iAUC EPA from 0 to 24hours (iAUC0-24h) between two study products	0h-24h (on Day 2 and Day 16)	Blood concentrations for EPA in plasma at 0h and 24h will be analyzed, and iAUC0-24h will be calculated. After getting the iAUC0-24h, 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 24h is defined as 24 hours after the intake of supplement.
Comparison of iAUC EPA from 0 to 72hours (iAUC0-72h) between two study products	0h-72h (on Day 4 and Day 18)	Blood concentrations for EPA in plasma at 0h and 72h will be analyzed, and iAUC0-72h will be calculated. After getting the iAUC0-72h, 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 72h is defined as 72 hours after the intake of supplement.
Difference on Cmax of EPA+DHA between two products	Day 1 and Day 15	Cmax of EPA+DHA will be calculated for both products, and the difference will be compared between the products.
Difference on Cmax of EPA between two products	Day 1 and Day 15	Cmax of EPA will be calculated for both products, and the difference will be compared between the products.
Difference on total omega 6 fatty acids vs total omega 3 fatty acid ratio (n-6/n-3) in plasma at 24 hours between two products	Day 2 and Day 16	Total omega 6 fatty acids include: linoleic acid, γ-Linolenic acid, eicosadienoic acid, eicosatrienoic acid, arachidonic acid, adrenic acid, and docosapentaenoic acid. Total omega 3 fatty acids include: α-Linolenic acid, EPA, docosapentaenoate acid and DHA. The difference on n-6/n-3 ratio will be calculated between two products.; The time point 24h is defined as 24 hours after the intake of supplement.
Difference on Cmax of DHA between two products	Day 1 and Day 15	Cmax of DHA will be calculated for both products, and the difference will be compared between the products.
Difference on Tmax of EPA between two products	Day 1 and Day 15	Tmax of EPA will be calculated for both products, and the difference will be compared between the products.
Difference on total omega 6 fatty acids vs total omega 3 fatty acid ratio (n-6/n-3) in plasma at 72 hours between two products	Day 4 and Day 18	Total omega 6 fatty acids include: linoleic acid, γ-Linolenic acid, eicosadienoic acid, eicosatrienoic acid, arachidonic acid, adrenic acid, and docosapentaenoic acid. Total omega 3 fatty acids include: α-Linolenic acid, EPA, docosapentaenoate acid and DHA. The difference on n-6/n-3 ratio will be calculated between two products.; The time point 72h is defined as 72 hours after the intake of supplement.

Trial Locations

Locations (1)

BioTeSys GmbH; 🇩🇪 Esslingen, Germany