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

Maartje van den Belt

Status: Begins enrollment in 1 month

Conditions: Postprandial Bioavailability DHA; Fatty Acid Metabolism; Functional Immune Response

Treatments: Dietary Supplement: Algae oil 2; Dietary Supplement: Algae oil 1; Dietary Supplement: Fish oil (control)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07086573

2023-16979

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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12 participants in 3 patient groups

Fish oil (control)

Active Comparator group

Description:

Tuna oil

Treatment:

Dietary Supplement: Fish oil (control)

Algae oil supplement 1

Experimental group

Description:

Algae oil 1

Treatment:

Dietary Supplement: Algae oil 1

Algae oil supplement 2

Experimental group

Description:

Algae oil 2

Treatment:

Dietary Supplement: Algae oil 2