NutritionOcean's O3NCT06665464
Bioavailability of Omega-3 Fatty Acids From Fish Oil Supplements
A study testing Fish oil supplement 1 and Fish oil supplement 2 in people with Nutrition and Absorption, Metabolism and Excretion in Healthy Volunteers, run by Wageningen University and Research at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Absorption, Metabolism and Excretion in Healthy Volunteers, Fish Oils
- What is being tested?
- Fish oil supplement 1 and Fish oil supplement 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Nov 2024to 19 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Fish oil supplement 1, Fish oil supplement 2
- Keywords
- Omega 3 fatty acids, bioavailability, oral supplement, fish oil supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oil supplement 1Dietary supplement
Soft gel capsule
Fish oil supplement 2Dietary supplement
Soft gel chewable
| Study group | Role | What they receive |
|---|---|---|
| Fish oil supplement 1 | Active comparator | Not described Receives: Dietary Supplement: Fish oil supplement 1 |
| Fish oil supplement 2 | Experimental | Not described Receives: Dietary Supplement: Fish oil supplement 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Between baseline and 24 hours
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Between baseline and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start20 Nov 2024
- Primary completion19 Dec 2024
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This intervention study has a randomized, cross-over, open label design
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University and Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lonneke Janssen Duijghuijsen, Wageningen University and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665464
- Sponsor's protocol ID
- NL87485.041.24
- Acronym
- Ocean's O3
- Status last verified
- May 2025
- First submitted
- 29 Oct 2024
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No consent from study participants
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Omega-3 Fatty Acids From Fish Oil Supplements
- ClinicalTrials.gov ID
- NCT06665464
- Acronym / sponsor ID
- Ocean's O3 / NL87485.041.24
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Wageningen University and ResearchUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This intervention study has a randomized, cross-over, open label design
| Arm | Type | Receives |
|---|---|---|
| Fish oil supplement 1 | Active comparator | Dietary Supplement: Fish oil supplement 1 |
| Fish oil supplement 2 | Experimental | Dietary Supplement: Fish oil supplement 2 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish oil supplement 1Soft gel capsule | Dietary supplement | Fish oil supplement 1 |
| Fish oil supplement 2Soft gel chewable | Dietary supplement | Fish oil supplement 2 |
Primary outcome
The area under the curve of combined EPA and DHA plasma levels in venous blood samples
Time frame: Between baseline and 24 hours
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
8 secondary outcomes
The time to peak for combined EPA and DHA plasma levels
Time frame: Between baseline and 24 hours
The maximum peak height for combined EPA and DHA plasma levels
Time frame: Between baseline and 24 hours
The area under the curve of DHA plasma levels in venous blood samples
Time frame: Between baseline and 24 hours
The area under the curve of EPA plasma levels in venous blood samples
Time frame: Between baseline and 24 hours
The time to peak for DHA plasma levels
Time frame: Between baseline and 24 hours
The time to peak for EPA plasma levels
Time frame: Between baseline and 24 hours
The maximum peak height for EPA plasma levels
Time frame: Between baseline and 24 hours
The maximum peak height for DHA plasma levels
Time frame: Between baseline and 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: No. No consent from study participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish oil supplement 1 and Fish oil supplement 2 in people with Nutrition and Absorption, Metabolism and Excretion in Healthy Volunteers, run by Wageningen University and Research at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The area under the curve of combined EPA and DHA plasma levels in venous blood samples (time frame: Between baseline and 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.