Bioavailability of Omega-3 Fatty Acids From Fish Oil Supplements

NCT ID: NCT06665464

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-20
• Study Completion Date: 2024-12-19

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

Study Design

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

Study Groups

Fish oil supplement 1

Group Type: ACTIVE_COMPARATOR

Fish oil supplement 1

Intervention Type: DIETARY_SUPPLEMENT

Soft gel capsule

Fish oil supplement 2

Group Type: EXPERIMENTAL

Fish oil supplement 2

Intervention Type: DIETARY_SUPPLEMENT

Soft gel chewable

Interventions

Fish oil supplement 1

Soft gel capsule

Intervention Type: DIETARY_SUPPLEMENT

Fish oil supplement 2

Soft gel chewable

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wageningen University and Research

OTHER

Sponsor Role: lead

Responsible Party

Lonneke Janssen Duijghuijsen

Researcher Clinical Trials

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Wageningen University & Research

Wageningen, , Netherlands

Countries

Netherlands

Other Identifiers

NL87485.041.24

Identifier Type: -

Identifier Source: org_study_id