Fatty Acid Metabolism, Functional Immune Response, Postprandial Bioavailability DHA
Conditions
Keywords
Immune function, DHA bioavailability, ALG study, Algae oil, Omega-3
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.
Interventions
DIETARY_SUPPLEMENTFish oil (control)
Tuna oil
DIETARY_SUPPLEMENTAlgae oil 1
DHA Origins 550-Y oil (Fermentalg)
DIETARY_SUPPLEMENTAlgae oil 2
Oleo H-02 (Microalgas)
Sponsors
Nutricia Research
Fermentalg
Microalgas Oleas de México, S.A. de C.V.
Utrecht University
Maartje van den Belt
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
The study is a randomized, crossover, double-blind, controlled study of 7 weeks with 3 study arms.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional immune response | Baseline (0 hours) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma DHA levels | Baseline (0 hours) | Measured in venous blood samples. DHA will be determined by gas chromatography. |
| Fatty acid levels in plasma and PBMCs | Baseline (0 hours) | Measured in plasma and PBMCs, fatty acids will be determined by gas chromatography. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fatty acid levels in cell membranes of erythrocytes | Baseline (0 hours) | Fatty acid levels in cell membranes of erythrocytes will be determined by gas chromatography |
| Plasma EPA levels | Baseline (0 hours) | Measured in venous blood samples. Plasma EPA will be determined by gas chromatography |
| Short term well-being | Baseline (0 hours) | Short-term well-being assessed by the Multidimensional Mood Questionnaire (MDMQ) |
| Gastrointestinal complaints | Baseline (0 hours) | Abdominal pain, bloating, flatulence, gastric acid, nausea, diarrhea on a VAS scale (0-10) |
| Functional immune response in plasma | Baseline | The ratio of pro (PGE2, IL-1β, IL-6, IL-8, IFNg, TNFα, CCL2 and CCL5) and anti-inflammatory markers (IL-4 and IL-10) will be determined using ELISA kits or a custom LegendPlex. |
| Oxylipin levels in plasma | Baseline (0 hours) | Oxylipin levels will be determined by LC-MS/MS after solid phase extraction |
Countries
Netherlands
Contacts
Primary ContactMaartje van den Belt, MSc
Backup ContactLonneke Janssen Duijghuijsen, PhD
Outcome results
None listed