The primary objective is to estimate functional immune response in isolated peripheral blood mononuclear cells (PBMCs; ratio of pro-inflammatory; i.e. PGE2, IL-1β, IL-6, IL-8, IFN*, TNFα, CCL2 and CCL5, and anti-inflammatory markers; i.e.,…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Immuun functie, opname van omega-3 vetzuren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the functional immune response (ratio pro- and
anti-inflammatory markers) measured in isolated PBMCs, collected at 0 hours
(baseline), 4 hours, and 8 hours after consumption of the omega-3-rich
supplements, and after 1-week exposure to the supplements.
Secondary outcome
The secondary study parameters are the DHA levels in blood and fatty acid
levels in plasma and PBMCs, taken before and after the consumption of
omega-3-rich supplements.
Background summary
During aging the immune system is weakened, increasing the vulnerability and
severity of infectious diseases and the incidence of cancer and low-grade
inflammation in elderly people. Adequate intake of Eicosapentaenoic acid (EPA)
and docosahexaenoic acid (DHA) omega-3 fatty acids is crucial for a properly
functioning immune system, healthy brain development, and preventing conditions
such as cardiovascular diseases. Unfortunately, the intake of EPA and DHA
through diet remains below the recommended levels for certain target groups,
such as the elderly, vegans and vegetarians. This leads to an increasing demand
for omega-3 fatty acid supplements. Due to sustainability reasons and evolving
lifestyle trends, consumers often seek omega-3 products not derived from fish,
creating a need for sustainable alternatives. The use of omega-3 fatty acids
from microalgae is therefore an attractive alternative. However, little is
known about how omega-3 fatty acids from algae oil supplements affect immune
responses compared to fish oil supplements.
Study objective
The primary objective is to estimate functional immune response in isolated
peripheral blood mononuclear cells (PBMCs; ratio of pro-inflammatory; i.e.
PGE2, IL-1β, IL-6, IL-8, IFN*, TNFα, CCL2 and CCL5, and anti-inflammatory
markers; i.e., IL-4 and IL-10) 0, 4, 8 hours, and 1 week after consumption of
two different oil supplements and a fish oil supplement (control) in healthy
elderly adults. The secondary objectives are 1) to estimate the postprandial
DHA bioavailability in blood, and the ratio with triglycerides, after
consumption of two different oil supplements and a fish oil supplement
(control) in healthy elderly adults, and 2) to estimate fatty acid levels in
plasma, and PBMCs at baseline and after 1-week consumption of two different oil
supplements and a fish oil supplement (control) in healthy elderly adults.
Tertiary objectives include 1) to estimate the postprandial EPA bioavailability
in blood after consumption of two different oil supplements and a fish oil
supplement (control) in healthy elderly adults, 2) to estimate oxylipin levels
in plasma at 0, 4, 8 hours, and after 1 week after consumption of two different
oil supplement and a fish oil supplement (control) in healthy elderly adults,
3) to estimate the ratio of postprandial pro- and anti-inflammatory markers in
blood plasma (Pro-inflammatory; PGE2, IL-1β, IL-6, IL-8,IFN*, TNFα, CCL2 and
CCL5, anti-inflammatory; IL-4 and IL-10) 0, 4, 8 hours and after 1 week after
consumption of two different oil supplements and a fish oil supplement
(control) in healthy elderly adults, 4) to estimate gastrointestinal symptoms
(gastric acid, nausea, diarrhea, abdominal pain, flatulence, bloating), and
short-term well-being/mood before and 4 hours, 8 hours, and 1-week after
consumption of two different oil supplements and a fish oil supplement
(control) in healthy elderly adults, and 5) estimate fatty acid levels in cell
membranes of erythrocytes at baseline and after 1-week consumption of two
different oil supplements and a fish oil supplement (control) in healthy
elderly adults.
Study design
The study is a randomized, crossover, double-blind, controlled study.
Intervention
During each postprandial test day, the subjects receive one of the 3
omega-3-rich supplements (one of 2 types of algae oil supplements or a fish oil
supplement control) in capsule form (6 capsules per test day), in a randomized
order. After each postprandial test day, the study subjects take 6 capsules per
day of the same supplement for one week. After each treatment there will be a
wash-out period of 2 weeks.
Study burden and risks
There are minor risks for the participants in this study. There are no direct
benefits for the participants. In this research, we include healthy subjects
based on the research criteria and a health questionnaire. The total amount of
blood taken (678 ml) is spread over a minimum of seven weeks, and individuals
with anemia are excluded. Therefore, blood collection is not expected to pose
any issues. Participants involved in the study will invest approximately 34
hours in the research.
Bornse Weilanden 9
Wageningen 6708WG
NL
Bornse Weilanden 9
Wageningen 6708WG
NL
Listed location countries
Age
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.
Design
Recruitment
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In other registers
| Register | ID |
|---|---|
| CCMO | NL85977.091.23 |