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

NCT07086573 | Not Yet Recruiting

• 1 other identifier: 2023-16979
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Functional Immune Response; Postprandial Bioavailability DHA; Fatty Acid Metabolism

Keywords

Immune function; DHA bioavailability; ALG study; Algae oil; Omega-3

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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).

  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).

  1 week after exposure to the oil

Secondary Outcomes (11)

• Plasma DHA levels

  Baseline (0 hours)

• Plasma DHA levels

  1 hour postprandial

• Plasma DHA levels

  2 hours postprandial

• Plasma DHA levels

  3 hours postprandial

• Plasma DHA levels

  4 hours postprandial

Other Outcomes (34)

• Plasma EPA levels

  Baseline (0 hours)

• Plasma EPA levels

  1 hour postprandial

• Plasma EPA levels

  2 hours postprandial

Study Arms (3)

Fish oil (control)

ACTIVE COMPARATOR

Tuna oil

Dietary Supplement: Fish oil (control)

Algae oil supplement 1

EXPERIMENTAL

Algae oil 1

Dietary Supplement: Algae oil 1

Algae oil supplement 2

EXPERIMENTAL

Algae oil 2

Dietary Supplement: Algae oil 2

Interventions

Algae oil 1 DIETARY_SUPPLEMENT

DHA Origins 550-Y oil (Fermentalg)

Algae oil supplement 1

Algae oil 2 DIETARY_SUPPLEMENT

Oleo H-02 (Microalgas)

Algae oil supplement 2

Fish oil (control) DIETARY_SUPPLEMENT

Tuna oil

Fish oil (control)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maartje van den Belt: lead
• Nutricia Research: collaborator
• Fermentalg: collaborator
• Microalgas Oleas de México, S.A. de C.V.: collaborator
• Utrecht University: collaborator

Study Sites (1)

Wageningen University & Research

Wageningen, Gelderland, 6700 AA, Netherlands

Location

MeSH Terms

Interventions

Fish Oils

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Maartje van den Belt, MSc

  Wageningen Food and Biobased Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maartje van den Belt, MSc

CONTACT

0031618520632; maartje.vandenbelt@wur.nl

Lonneke Janssen Duijghuijsen, PhD

CONTACT

+31317489390; lonneke.janssenduijghuijsen@wur.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher Food, Health & Consumer research

Model Details: The study is a randomized, crossover, double-blind, controlled study of 7 weeks with 3 study arms.

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 25, 2025
• Study Start: September 22, 2025
• Primary Completion: November 14, 2025
• Study Completion: November 14, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)