Menu
Not yet recruiting NCT07086573

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

No phase Interventional Functional Immune Response Postprandial Bioavailability DHA Fatty Acid Metabolism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Algae oil 1, Algae oil 2, Fish oil (control).
Who it may be relevant to
Registry conditions: Functional Immune Response, Postprandial Bioavailability DHA, Fatty Acid Metabolism. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Dietary supplement Algae oil 1
    DHA Origins 550-Y oil (Fermentalg)
  • Dietary supplement Algae oil 2
    Oleo H-02 (Microalgas)
  • Dietary supplement Fish oil (control)
    Tuna oil

Primary outcome measures

  • Functional immune response [Time frame: Baseline (0 hours)]
  • Functional immune response [Time frame: 4 hours postprandial]
  • Functional immune response [Time frame: 8 hours postprandial]
  • Functional immune response [Time frame: 1 week after exposure to the oil]
Secondary outcome measures (11)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Other

Study locations

Netherlands · 1 center
  • Wageningen University & Research — Wageningen

Identifiers

NCT: NCT07086573 · 2023-16979

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗