Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07086573

The Effect of Algae Oil Supplements on Functional Immune Response and Bioavailability of Lipids in Blood, a Pilot 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Functional Immune Response Fatty Acid Metabolism Postprandial Bioavailability DHA

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University & Research

Wageningen, Gelderland, 6700 AA, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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, 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;
  • 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.

Treatment and study plan

Algae oil 1

Dietary Supplement

DHA Origins 550-Y oil (Fermentalg)

Algae oil 2

Dietary Supplement

Oleo H-02 (Microalgas)

Fish oil (control)

Dietary Supplement

Tuna oil

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

Secondary outcomes

  1. Plasma DHA levels

    Time frame: Baseline (0 hours)

    Measured in venous blood samples. DHA will be determined by gas chromatography.

  2. Plasma DHA levels

    Time frame: 1 hour postprandial

    Measured in venous blood samples. DHA will be determined by gas chromatography.

  3. Plasma DHA levels

    Time frame: 2 hours postprandial

    Measured in venous blood samples. DHA will be determined by gas chromatography.

  4. Plasma DHA levels

    Time frame: 3 hours postprandial

    Measured in venous blood samples. DHA will be determined by gas chromatography.

  5. Plasma DHA levels

    Time frame: 4 hours postprandial

    Measured in venous blood samples. DHA will be determined by gas chromatography.

  6. Plasma DHA levels

    Time frame: 5 hours postprandial

    Measured in venous blood samples. DHA will be determined by gas chromatography.

  7. Plasma DHA levels

    Time frame: 6 hours postprandial

    Measured in venous blood samples. DHA will be determined by gas chromatography.

  8. Plasma DHA levels

    Time frame: 7 hours postprandial

    Measured in venous blood samples. DHA will be determined by gas chromatography.

  9. Plasma DHA levels

    Time frame: 8 hours postprandial

    Measured in venous blood samples. DHA will be determined by gas chromatography.

  10. Fatty acid levels in plasma and PBMCs

    Time frame: Baseline (0 hours)

    Measured in plasma and PBMCs, fatty acids will be determined by gas chromatography.

  11. Fatty acid levels in plasma and PBMCs

    Time frame: 1 week after exposure to the oil

    Measured in plasma and PBMCs, fatty acids will be determined by gas chromatography.

Other outcomes

  1. Plasma EPA levels

    Time frame: Baseline (0 hours)

    Measured in venous blood samples. Plasma EPA will be determined by gas chromatography

  2. Plasma EPA levels

    Time frame: 1 hour postprandial

    Measured in venous blood samples. Plasma EPA will be determined by gas chromatography

  3. Plasma EPA levels

    Time frame: 2 hours postprandial

    Measured in venous blood samples. Plasma EPA will be determined by gas chromatography

  4. Plasma EPA levels

    Time frame: 3 hours postprandial

    Measured in venous blood samples. Plasma EPA will be determined by gas chromatography

  5. Plasma EPA levels

    Time frame: 4 hours postprandial

    Measured in venous blood samples. Plasma EPA will be determined by gas chromatography

  6. Plasma EPA levels

    Time frame: 5 hours postprandial

    Measured in venous blood samples. Plasma EPA will be determined by gas chromatography

  7. Plasma EPA levels

    Time frame: 6 hours postprandial

    Measured in venous blood samples. Plasma EPA will be determined by gas chromatography

  8. Plasma EPA levels

    Time frame: 7 hours postprandial

    Measured in venous blood samples. Plasma EPA will be determined by gas chromatography

  9. Plasma EPA levels

    Time frame: 8 hours postprandial

    Measured in venous blood samples. Plasma EPA will be determined by gas chromatography

  10. Functional immune response in plasma

    Time frame: Baseline

    The ratio of pro (PGE2, IL-1β, IL-6, IL-8, IFNg, TNFα, CCL2 and CCL5) and anti-inflammatory markers (IL-4 and IL-10) will be determined using ELISA kits or a custom LegendPlex.

  11. Functional immune response in plasma

    Time frame: 1 hour postprandial

    The ratio of pro (PGE2, IL-1β, IL-6, IL-8, IFNg, TNFα, CCL2 and CCL5) and anti-inflammatory markers (IL-4 and IL-10) will be determined using ELISA kits or a custom LegendPlex.

  12. Functional immune response in plasma

    Time frame: 2 hours postprandial

    The ratio of pro (PGE2, IL-1β, IL-6, IL-8, IFNg, TNFα, CCL2 and CCL5) and anti-inflammatory markers (IL-4 and IL-10) will be determined using ELISA kits or a custom LegendPlex.

  13. Functional immune response in plasma

    Time frame: 3 hours postprandial

    The ratio of pro (PGE2, IL-1β, IL-6, IL-8, IFNg, TNFα, CCL2 and CCL5) and anti-inflammatory markers (IL-4 and IL-10) will be determined using ELISA kits or a custom LegendPlex.

  14. Functional immune response in plasma

    Time frame: 4 hours postprandial

    The ratio of pro (PGE2, IL-1β, IL-6, IL-8, IFNg, TNFα, CCL2 and CCL5) and anti-inflammatory markers (IL-4 and IL-10) will be determined using ELISA kits or a custom LegendPlex.

  15. Functional immune response in plasma

    Time frame: 5 hours postprandial

    The ratio of pro (PGE2, IL-1β, IL-6, IL-8, IFNg, TNFα, CCL2 and CCL5) and anti-inflammatory markers (IL-4 and IL-10) will be determined using ELISA kits or a custom LegendPlex.

  16. Functional immune response in plasma

    Time frame: 6 hours postprandial

    The ratio of pro (PGE2, IL-1β, IL-6, IL-8, IFNg, TNFα, CCL2 and CCL5) and anti-inflammatory markers (IL-4 and IL-10) will be determined using ELISA kits or a custom LegendPlex.

  17. Functional immune response in plasma

    Time frame: 7 hours postprandial

    The ratio of pro (PGE2, IL-1β, IL-6, IL-8, IFNg, TNFα, CCL2 and CCL5) and anti-inflammatory markers (IL-4 and IL-10) will be determined using ELISA kits or a custom LegendPlex.

  18. Functional immune response in plasma

    Time frame: 8 hours postprandial

    The ratio of pro (PGE2, IL-1β, IL-6, IL-8, IFNg, TNFα, CCL2 and CCL5) and anti-inflammatory markers (IL-4 and IL-10) will be determined using ELISA kits or a custom LegendPlex.

  19. Oxylipin levels in plasma

    Time frame: Baseline (0 hours)

    Oxylipin levels will be determined by LC-MS/MS after solid phase extraction

  20. Oxylipin levels in plasma

    Time frame: 4 hours postprandial

    Oxylipin levels will be determined by LC-MS/MS after solid phase extraction

  21. Oxylipin levels in plasma

    Time frame: 8 hours postprandial

    Oxylipin levels will be determined by LC-MS/MS after solid phase extraction

  22. Oxylipin levels in plasma

    Time frame: 1 week after exposure to the oil

    Oxylipin levels will be determined by LC-MS/MS after solid phase extraction

  23. Fatty acid levels in cell membranes of erythrocytes

    Time frame: Baseline (0 hours)

    Fatty acid levels in cell membranes of erythrocytes will be determined by gas chromatography

  24. Fatty acid levels in cell membranes of erythrocytes

    Time frame: 1 week after exposure to the oil

    Fatty acid levels in cell membranes of erythrocytes will be determined by gas chromatography

  25. Gastrointestinal complaints

    Time frame: Baseline (0 hours)

    Abdominal pain, bloating, flatulence, gastric acid, nausea, diarrhea on a VAS scale (0-10)

  26. Gastrointestinal complaints

    Time frame: 4 hours postprandial

    Abdominal pain, bloating, flatulence, gastric acid, nausea, diarrhea on a VAS scale (0-10)

  27. Gastrointestinal complaints

    Time frame: 8 hours postprandial

    Abdominal pain, bloating, flatulence, gastric acid, nausea, diarrhea on a VAS scale (0-10)

  28. Gastrointestinal complaints

    Time frame: 12 hours postprandial

    Abdominal pain, bloating, flatulence, gastric acid, nausea, diarrhea on a VAS scale (0-10)

  29. Gastrointestinal complaints

    Time frame: 1 week after exposure to the oil

    Abdominal pain, bloating, flatulence, gastric acid, nausea, diarrhea on a VAS scale (0-10)

  30. Short term well-being

    Time frame: Baseline (0 hours)

    Short-term well-being assessed by the Multidimensional Mood Questionnaire (MDMQ)

  31. Short term well-being

    Time frame: 4 hours postprandial

    Short-term well-being assessed by the Multidimensional Mood Questionnaire (MDMQ)

  32. Short term well-being

    Time frame: 8 hours postprandial

    Short-term well-being assessed by the Multidimensional Mood Questionnaire (MDMQ)

  33. Short term well-being

    Time frame: 12 hours postprandial

    Short-term well-being assessed by the Multidimensional Mood Questionnaire (MDMQ)

  34. Short term well-being

    Time frame: 1 week after exposure to the oil

    Short-term well-being assessed by the Multidimensional Mood Questionnaire (MDMQ)

Study contacts

Contact information is provided by the study sponsor or research team.

Lonneke Janssen Duijghuijsen, PhD

CONTACT

[email protected]

+31317489390

Maartje van den Belt, MSc

CONTACT

[email protected]

0031618520632

Sponsors and collaborators

Lead sponsor

Maartje van den Belt

Other

Collaborators

  • Fermentalg
  • Microalgas Oleas de México, S.A. de C.V.
  • Nutricia Research
  • Utrecht University

Registry information

Acronym: ALG

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.