The effect of algae oil supplements on functional immune response and bioavailability of lipids in blood, a pilot study

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 12

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 one 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 in-hibitors 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 or Food
Quality and Design of Wageningen Food & Biobased Research.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter is the functional immune response (ratio pro- and<br /><br>anti-inflammatory markers) measured in isolated PBMCs, collected at 0 hours<br /><br>(baseline), 4 hours, and 8 hours after consumption of the omega-3-rich<br /><br>supplements, and after 1-week exposure to the supplements.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters are the DHA levels in blood and fatty acid<br /><br>levels in plasma and PBMCs, taken before and after the consumption of<br /><br>omega-3-rich supplements.</p><br>