Bioavailability of Omega-3 Fatty Acids From Fish Oil Supplements (Ocean's O3)

This study is investigating whether a new type of fish oil supplement, in the form of soft chews, leads to better absorption of omega-3s in the body compared to traditional fish oil capsules. Omega-3s, found in fish oil, are known to support heart health and reduce inflammation, but they may absorb better in certain forms. In this study, participants will take both types of supplements (soft chews and capsules) at different times to compare how well the omega-3s are absorbed. Researchers will measure the levels of omega-3s in the blood over several hours to determine if the soft chews offer a better option for people seeking the health benefits of omega-3s.

Study Overview

• Status: Completed
• Conditions: Nutrition; Omega 3 Fatty Acids; Absorption, Metabolism and Excretion in Healthy Volunteers; Fish Oils
• Intervention / Treatment: Dietary supplement: Fish oil supplement 1; Dietary supplement: Fish oil supplement 2

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Wageningen, Netherlands
    • Wageningen University & Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Apparently healthy adults (18 - 50 yrs);
• Body mass index (BMI) ≥18.5 and ≤30 kg/m2;
• Having veins suitable for blood sampling via a catheter (judged by study nurse/ medical doctor);
• Willing to refrain from fish, fish oil, and products with added omega-3 starting from 2 weeks prior to the first postprandial test day and during the study period;
• Willing to keep a stable dietary pattern throughout the study.

Exclusion Criteria:

• Having a disease that may interfere with the outcomes of this study, such as a known metabolic, gastrointestinal, inflammatory or chronic disease (such as anaemia, diabetes, hepatitis, hypercholesterolemia, cardiovascular disease), as judged by the medical investigator.
• Having a history of medical or surgical events that may significantly affect the study outcome, including: inflammatory bowel disease, pancreatitis, ulcers, gastrointestinal or rectal bleeding; major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; known or suspected gastrointestinal disorders, colon or GI tract cancer;
• Use of medication that may interfere with the study outcomes, including gastric acid inhibitors, laxatives, and lipid lowering drugs, as judged by the medical supervisor;
• Anaemia (Haemoglobin (Hb) values <7.5 mmol/L for women and <8.5 mmol/L for men), as assessed by finger prick blood during screening visit; NL87485.041.24 Ocean's O3
• Allergic for fish;
• Having swallowing problems with capsules;
• Recent blood donation (<1 month prior to test day 1 of the study) or not willing to stop donation during and 1 month after the study;
• Average alcohol intake >21 (women) or >28 (men) glasses of alcoholic beverages per week;
• Reported to follow or having planned a slimming or medically prescribed diet;
• Use of recreational drugs;
• Current smokers, or stopped smoking in the last 3 months before study start;
• Insufficient proficiency in Dutch to understand information brochure and questionnaires
• Participation in any clinical trial including blood sampling and/or administration of substances up to 30 days before test day 1 of this study and during the study period;
• Being an employee of the department Food, Health & Consumer Research Wageningen Food & Biobased Research.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fish oil supplement 1	Dietary supplement: Fish oil supplement 1; Soft gel capsule
Experimental: Fish oil supplement 2	Dietary supplement: Fish oil supplement 2; Soft gel chewable

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The area under the curve of combined EPA and DHA plasma levels in venous blood samples	Venous blood samples collected at baseline (t=-15min and t=0) and at t=30, 60, 90, 120, 150, 180, 240, 360, 540, and 720min, and 24hours	Between baseline and 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time to peak for combined EPA and DHA plasma levels	Venous blood samples collected at baseline (t=-15min and t=0) and at t=30, 60, 90, 120, 150, 180, 240, 360, 540, and 720min, and 24hours	Between baseline and 24 hours
The maximum peak height for combined EPA and DHA plasma levels	Venous blood samples collected at baseline (t=-15min and t=0) and at t=30, 60, 90, 120, 150, 180, 240, 360, 540, and 720min, and 24hours	Between baseline and 24 hours
The area under the curve of DHA plasma levels in venous blood samples	Venous blood samples collected at baseline (t=-15min and t=0) and at t=30, 60, 90, 120, 150, 180, 240, 360, 540, and 720min, and 24hours	Between baseline and 24 hours
The area under the curve of EPA plasma levels in venous blood samples	Venous blood samples collected at baseline (t=-15min and t=0) and at t=30, 60, 90, 120, 150, 180, 240, 360, 540, and 720min, and 24hours	Between baseline and 24 hours
The time to peak for DHA plasma levels	Venous blood samples collected at baseline (t=-15min and t=0) and at t=30, 60, 90, 120, 150, 180, 240, 360, 540, and 720min, and 24hours	Between baseline and 24 hours
The time to peak for EPA plasma levels	Venous blood samples collected at baseline (t=-15min and t=0) and at t=30, 60, 90, 120, 150, 180, 240, 360, 540, and 720min, and 24hours	Between baseline and 24 hours
The maximum peak height for EPA plasma levels	Venous blood samples collected at baseline (t=-15min and t=0) and at t=30, 60, 90, 120, 150, 180, 240, 360, 540, and 720min, and 24hours	Between baseline and 24 hours
The maximum peak height for DHA plasma levels	Venous blood samples collected at baseline (t=-15min and t=0) and at t=30, 60, 90, 120, 150, 180, 240, 360, 540, and 720min, and 24hours	Between baseline and 24 hours

Collaborators and Investigators

• Sponsor: Wageningen University and Research

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2024
• Primary Completion (Actual): December 19, 2024
• Study Completion (Actual): December 19, 2024

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: October 29, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: bioavailability; Omega 3 fatty acids; oral supplement; fish oil supplement
• Other Study ID Numbers: NL87485.041.24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No consent from study participants

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No