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

NCT ID: NCT07086573

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-22
• Study Completion Date: 2025-11-14

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Fish oil (control)

Tuna oil

Group Type: ACTIVE_COMPARATOR

Fish oil (control)

Intervention Type: DIETARY_SUPPLEMENT

Tuna oil

Algae oil supplement 1

Algae oil 1

Group Type: EXPERIMENTAL

Algae oil 1

Intervention Type: DIETARY_SUPPLEMENT

DHA Origins 550-Y oil (Fermentalg)

Algae oil supplement 2

Algae oil 2

Group Type: EXPERIMENTAL

Algae oil 2

Intervention Type: DIETARY_SUPPLEMENT

Oleo H-02 (Microalgas)

Interventions

Algae oil 1

DHA Origins 550-Y oil (Fermentalg)

Intervention Type: DIETARY_SUPPLEMENT

Algae oil 2

Oleo H-02 (Microalgas)

Intervention Type: DIETARY_SUPPLEMENT

Fish oil (control)

Tuna oil

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nutricia Research

INDUSTRY

Sponsor Role: collaborator

Fermentalg

UNKNOWN

Sponsor Role: collaborator

Microalgas Oleas de México, S.A. de C.V.

UNKNOWN

Sponsor Role: collaborator

Utrecht University

OTHER

Sponsor Role: collaborator

Maartje van den Belt

OTHER

Sponsor Role: lead

Responsible Party

Maartje van den Belt

Researcher Food, Health & Consumer research

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Maartje van den Belt, MSc

Role: PRINCIPAL_INVESTIGATOR

Wageningen Food and Biobased Research

Locations

Wageningen University & Research

Wageningen, Gelderland, Netherlands

Countries

Netherlands

Central Contacts

Maartje van den Belt, MSc

Role: CONTACT

maartje.vandenbelt@wur.nl

0031618520632

Lonneke Janssen Duijghuijsen, PhD

Role: CONTACT

lonneke.janssenduijghuijsen@wur.nl

+31317489390

Other Identifiers

2023-16979

Identifier Type: -

Identifier Source: org_study_id