Bioavailability of Omega-3 Fatty Acids From Fish Oil Supplements

NCT06665464 | Completed

• 1 other identifier: NL87485.041.24
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nutrition; Absorption, Metabolism and Excretion in Healthy Volunteers; Fish Oils; Omega 3 Fatty Acids

Keywords

Omega 3 fatty acids; bioavailability; oral supplement; fish oil supplement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• The time to peak for combined EPA and DHA plasma levels

  Between baseline and 24 hours

• The maximum peak height for combined EPA and DHA plasma levels

  Between baseline and 24 hours

• The area under the curve of DHA plasma levels in venous blood samples

  Between baseline and 24 hours

• The area under the curve of EPA plasma levels in venous blood samples

  Between baseline and 24 hours

• The time to peak for DHA plasma levels

  Between baseline and 24 hours

Study Arms (2)

Fish oil supplement 1

ACTIVE COMPARATOR

Dietary Supplement: Fish oil supplement 1

Fish oil supplement 2

EXPERIMENTAL

Dietary Supplement: Fish oil supplement 2

Interventions

Fish oil supplement 1 DIETARY_SUPPLEMENT

Soft gel capsule

Fish oil supplement 1

Fish oil supplement 2 DIETARY_SUPPLEMENT

Soft gel chewable

Fish oil supplement 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wageningen University and Research: lead

Study Sites (1)

Wageningen University & Research

Wageningen, Netherlands

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The researchers performing the sample and data analyses will be blinded until all analyses are finalized.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher Clinical Trials

Model Details: This intervention study has a randomized, cross-over, open label design

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 30, 2024
• Study Start: November 20, 2024
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)