The Effect of Algae Oil Supplements on Functional Immune... | NCT07086573

Status Module

Name	Class
Nutricia Research	INDUSTRY
Fermentalg	UNKNOWN
Microalgas Oleas de México, S.A. de C.V.	UNKNOWN
Utrecht University

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Algae oil 1	Dietary Supplement	DHA Origins 550-Y oil (Fermentalg)	Algae oil supplement 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Plasma DHA levels	Measured in venous blood samples. DHA will be determined by gas chromatography.	Baseline (0 hours)
Plasma DHA levels	Measured in venous blood samples. DHA will be determined by gas chromatography.

Other Outcomes

Measure	Description	Time Frame
Plasma EPA levels	Measured in venous blood samples. Plasma EPA will be determined by gas chromatography	Baseline (0 hours)
Plasma EPA levels	Measured in venous blood samples. Plasma EPA will be determined by gas chromatography

Eligibility Module

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.

Name	Role	Phone	Extension	Email
Maartje van den Belt, MSc	Contact	0031618520632		maartje.vandenbelt@wur.nl
Lonneke Janssen Duijghuijsen, PhD	Contact	+31317489390		lonneke.janssenduijghuijsen@wur.nl

ID	Term
D009821	Oils
D008055	Lipids