Functional Immune ResponseALGNCT07086573
The Effect of Algae Oil Supplements on Functional Immune Response and Bioavailability of Lipids in Blood, a Pilot Study
A study testing Algae oil 1 and Algae oil 2 in people with Functional Immune Response and Postprandial Bioavailability DHA, run by Maartje van den Belt at 1 site in Netherlands.
Trial summary
In this explorative study we will investigate whether two sustainable oil supplements yield equivalent results to fish oil supplements in terms of postprandial immune response, among elderly adults, after standardization of the quantity of DHA among the oils. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Functional Immune Response, Postprandial Bioavailability DHA, Fatty Acid Metabolism
- What is being tested?
- Algae oil 1 and Algae oil 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Sep 2025to 14 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apparently healthy men and women;
- Age ≥ 50 years
- 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 first postprandial test day.
- 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, 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, hepatitis, 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 or laxatives, 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;
- Having swallowing problems with capsules;
- Allergic for fish or shellfish;
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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 weight loss or weight gain of more than 3 kg in the month prior to pre-study screening, or intention to lose weight during the study period;
- Reported to follow or having planned a slimming or medically prescribed diet;
- Use of 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 sub-stances 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 or Food Quality and Design of Wageningen University.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Wageningen University & Research
Wageningen, Gelderland, 6700 AA
About this study
In this explorative study we will investigate whether two sustainable oil supplements yield equivalent results to fish oil supplements in terms of postprandial immune response, among elderly adults, after standardization of the quantity of DHA among the oils. Results on the bioavailability of DHA from different oil supplements will help determine whether differences in DHA bioavailability lead to differences in immune function. Additionally, we will investigate postprandial inflammatory markers. The outcomes of this exploratorive study will provide insight into the variation between individuals and potential effect sizes, and will aim to conduct more targeted follow-up studies on the effects of algae oils on immune function.
- Being tested
- Algae oil 1, Algae oil 2, Fish oil (control)
- Keywords
- Immune function, DHA bioavailability, ALG study, Algae oil, Omega-3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algae oil 1Dietary supplement
DHA Origins 550-Y oil (Fermentalg)
Algae oil 2Dietary supplement
Oleo H-02 (Microalgas)
Fish oil (control)Dietary supplement
Tuna oil
| Study group | Role | What they receive |
|---|---|---|
| Fish oil (control) | Active comparator | Tuna oil Receives: Dietary Supplement: Fish oil (control) |
| Algae oil supplement 1 | Experimental | Algae oil 1 Receives: Dietary Supplement: Algae oil 1 |
| Algae oil supplement 2 | Experimental | Algae oil 2 Receives: Dietary Supplement: Algae oil 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional immune response
Measured in isolated PBMCs by calculating the ratio of pro- and anti-inflammatory markers after ex vivo stimulation with LPS and measurement of the cytokine response. The following markers will be measured: pro inflammatory (PGE2, IL-1β, IL-6, IL-8, IFNg, TNFα, CCL2 and CCL5), anti-inflammatory (IL-4 and IL-10).
Measured: Baseline (0 hours)
Functional immune response
Measured in isolated PBMCs by calculating the ratio of pro- and anti-inflammatory markers after ex vivo stimulation with LPS and measurement of the cytokine response. The following markers will be measured: pro inflammatory (PGE2, IL-1β, IL-6, IL-8, IFNg, TNFα, CCL2 and CCL5), anti-inflammatory (IL-4 and IL-10).
Measured: 4 hours postprandial
Functional immune response
Measured in isolated PBMCs by calculating the ratio of pro- and anti-inflammatory markers after ex vivo stimulation with LPS and measurement of the cytokine response. The following markers will be measured: pro inflammatory (PGE2, IL-1β, IL-6, IL-8, IFNg, TNFα, CCL2 and CCL5), anti-inflammatory (IL-4 and IL-10).
Measured: 8 hours postprandial
Functional immune response
Measured in isolated PBMCs by calculating the ratio of pro- and anti-inflammatory markers after ex vivo stimulation with LPS and measurement of the cytokine response. The following markers will be measured: pro inflammatory (PGE2, IL-1β, IL-6, IL-8, IFNg, TNFα, CCL2 and CCL5), anti-inflammatory (IL-4 and IL-10).
Measured: 1 week after exposure to the oil
Secondary outcomes (11)
Plasma DHA levels
Measured in venous blood samples. DHA will be determined by gas chromatography.
Measured: Baseline (0 hours)
Plasma DHA levels
Measured in venous blood samples. DHA will be determined by gas chromatography.
Measured: 1 hour postprandial
Plasma DHA levels
Measured in venous blood samples. DHA will be determined by gas chromatography.
Measured: 2 hours postprandial
Plasma DHA levels
Measured in venous blood samples. DHA will be determined by gas chromatography.
Measured: 3 hours postprandial
Plasma DHA levels
Measured in venous blood samples. DHA will be determined by gas chromatography.
Measured: 4 hours postprandial
Plasma DHA levels
Measured in venous blood samples. DHA will be determined by gas chromatography.
Measured: 5 hours postprandial
Plasma DHA levels
Measured in venous blood samples. DHA will be determined by gas chromatography.
Measured: 6 hours postprandial
Plasma DHA levels
Measured in venous blood samples. DHA will be determined by gas chromatography.
Measured: 7 hours postprandial
Plasma DHA levels
Measured in venous blood samples. DHA will be determined by gas chromatography.
Measured: 8 hours postprandial
Fatty acid levels in plasma and PBMCs
Measured in plasma and PBMCs, fatty acids will be determined by gas chromatography.
Measured: Baseline (0 hours)
Fatty acid levels in plasma and PBMCs
Measured in plasma and PBMCs, fatty acids will be determined by gas chromatography.
Measured: 1 week after exposure to the oil
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start22 Sep 2025 (estimated)
- Primary completion14 Nov 2025 (estimated)
- Study completion14 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Immune ResponseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study is a randomized, crossover, double-blind, controlled study of 7 weeks with 3 study arms.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maartje van den Belt
- Sponsor type
- University, hospital or other
- Collaborators
- Nutricia Research, Fermentalg, Microalgas Oleas de México, S.A. de C.V., Utrecht University
- Responsible party
- Sponsor-investigator, Maartje van den Belt, Wageningen University and Research
- Investigators
- Maartje van den Belt, MSc, Principal investigator, Wageningen Food and Biobased Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086573
- Sponsor's protocol ID
- 2023-16979
- Other IDs
- 2023
- Acronym
- ALG
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since study participants did not give consent to share data with other parties.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Algae Oil Supplements on Functional Immune Response and Bioavailability of Lipids in Blood, a Pilot Study
- ClinicalTrials.gov ID
- NCT07086573
- Acronym / sponsor ID
- ALG / 2023-16979
- Keywords
- Immune function, DHA bioavailability, ALG study, Algae oil, Omega-3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Maartje van den BeltUniversity, hospital or other
- Collaborators
- Nutricia Research, Fermentalg, Microalgas Oleas de México, S.A. de C.V., Utrecht University
- Study start
- 22 Sep 2025 (estimated)
- Primary completion
- 14 Nov 2025 (estimated)
- Study completion
- 14 Nov 2025 (estimated)
- First posted
- 25 Jul 2025 (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.
In this explorative study we will investigate whether two sustainable oil supplements yield equivalent results to fish oil supplements in terms of postprandial immune response, among elderly adults, after standardization of the quantity of DHA among the oils. Results on the bioavailability of DHA from different oil supplements will help determine whether differences in DHA bioavailability lead to differences in immune function. Additionally, we will investigate postprandial inflammatory markers. The outcomes of this exploratorive study will provide insight into the variation between individuals and potential effect sizes, and will aim to conduct more targeted follow-up studies on the effects of algae oils on immune function.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study is a randomized, crossover, double-blind, controlled study of 7 weeks with 3 study arms.
| Arm | Type | Receives |
|---|---|---|
| Fish oil (control) | Active comparator | Dietary Supplement: Fish oil (control)Tuna oil |
| Algae oil supplement 1 | Experimental | Dietary Supplement: Algae oil 1Algae oil 1 |
| Algae oil supplement 2 | Experimental | Dietary Supplement: Algae oil 2Algae oil 2 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Apparently healthy men and women;
- Age ≥ 50 years
- 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 first postprandial test day.
Key exclusion criteria (15 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, 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, hepatitis, 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 or laxatives, 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;
- Having swallowing problems with capsules;
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 |
|---|---|---|
| Algae oil 1DHA Origins 550-Y oil (Fermentalg) | Dietary supplement | Algae oil supplement 1 |
| Algae oil 2Oleo H-02 (Microalgas) | Dietary supplement | Algae oil supplement 2 |
| Fish oil (control)Tuna oil | Dietary supplement | Fish oil (control) |
Primary outcome
Functional immune response
Time frame: Baseline (0 hours)
Measured in isolated PBMCs by calculating the ratio of pro- and anti-inflammatory markers after ex vivo stimulation with LPS and measurement of the cytokine response. The following markers will be measured: pro inflammatory (PGE2, IL-1β, IL-6, IL-8, IFNg, TNFα, CCL2 and CCL5), anti-inflammatory (IL-4 and IL-10).
Functional immune response
Time frame: 4 hours postprandial
Measured in isolated PBMCs by calculating the ratio of pro- and anti-inflammatory markers after ex vivo stimulation with LPS and measurement of the cytokine response. The following markers will be measured: pro inflammatory (PGE2, IL-1β, IL-6, IL-8, IFNg, TNFα, CCL2 and CCL5), anti-inflammatory (IL-4 and IL-10).
Functional immune response
Time frame: 8 hours postprandial
Measured in isolated PBMCs by calculating the ratio of pro- and anti-inflammatory markers after ex vivo stimulation with LPS and measurement of the cytokine response. The following markers will be measured: pro inflammatory (PGE2, IL-1β, IL-6, IL-8, IFNg, TNFα, CCL2 and CCL5), anti-inflammatory (IL-4 and IL-10).
Functional immune response
Time frame: 1 week after exposure to the oil
Measured in isolated PBMCs by calculating the ratio of pro- and anti-inflammatory markers after ex vivo stimulation with LPS and measurement of the cytokine response. The following markers will be measured: pro inflammatory (PGE2, IL-1β, IL-6, IL-8, IFNg, TNFα, CCL2 and CCL5), anti-inflammatory (IL-4 and IL-10).
11 secondary outcomes
Plasma DHA levels
Time frame: Baseline (0 hours)
Plasma DHA levels
Time frame: 1 hour postprandial
Plasma DHA levels
Time frame: 2 hours postprandial
Plasma DHA levels
Time frame: 3 hours postprandial
Plasma DHA levels
Time frame: 4 hours postprandial
Plasma DHA levels
Time frame: 5 hours postprandial
Plasma DHA levels
Time frame: 6 hours postprandial
Plasma DHA levels
Time frame: 7 hours postprandial
Plasma DHA levels
Time frame: 8 hours postprandial
Fatty acid levels in plasma and PBMCs
Time frame: Baseline (0 hours)
Fatty acid levels in plasma and PBMCs
Time frame: 1 week after exposure to the oil
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No. Since study participants did not give consent to share data with other parties.
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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.
Maartje van den Belt, MSc principal investigator
Wageningen Food and Biobased Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algae oil 1 and Algae oil 2 in people with Functional Immune Response and Postprandial Bioavailability DHA, run by Maartje van den Belt 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 6 inclusion and 15 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: opening soon, as of the sponsor's last update on 25 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maartje van den Belt, MSc (0031618520632, maartje.vandenbelt@wur.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional immune response (time frame: Baseline (0 hours)). The study lists 4 primary outcomes in all. 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 25 Jul 2025.