In Vitro And Ex Vivo Anti-Inflammatory Activities Of Salmon Polar Lipids
NCT ID: NCT03603769
Last Updated: 2019-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
6 participants
INTERVENTIONAL
2018-09-03
2019-01-31
Brief Summary
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Within this study, the postprandial effects of this novel food supplement against platelet aggregation and inflammation are going to be exploited ex vivo in blood from human subjects as described in previously established procedures.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
Within each appointment each participant will come (after fasting overnight, 10-12 h), to our metabolic unit early in the morning (07:30 - 08.30 am) and will initially give a fasting baseline blood sample. Afterwards, in specific time he/she will be provided to consume a standardized breakfast and then he/she will be administered randomly either placebo or several versions of the food supplement containing Salmon Polar Lipids (Low Dose stomach release or High Dose stomach release or Low Dose intestine release or High Dose Intestine Release). Thus, the sequence of the trials will be randomly selected for each subject.
PREVENTION
DOUBLE
Study Groups
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Group A: Food Supplement (Salmon Polar Lipids) Intervention
Experimental: After fasting overnight, subjects will come to our metabolic unit where in a randomized and double blinded way they will be provided several versions of the food supplement either of stomach resistant (intestine release) or stomach non-resistant (stomach release) each containing either 0.25 (Low Dose) or 0.50 g (High Dose) of Salmon Polar Lipids (SPL)
Assessment \& outcome measured: Blood samples will be taken from each subject at baseline (0 hours) and after 1-4 hours of the SPL-food supplement intervention. Aggregation of platelets will be assessed in these samples as previously described (see references 1-4), in order to evaluate the postprandial effects of this supplement on platelet aggregation.
Other blood coagulation parameters will also be evaluated, such as prothrombin time, fibrinogen, Activated partial thromboplastin time Plasma lipid profile (levels of plasma Total Cholesterol, LDL, HDL and Triglycerides) and serum CRP levels will also be assessed.
Food supplement capsules containing Salmon-Polar Lipids
Postprandial decreased Platelet activation/aggregation in subjects, after the food supplement capsule consumption
Group B: Consumption of Placebo Comparator
Experimental: After fasting overnight subjects will come to the metabolic unit in UL at 08.00 am where in a randomized and double blinded way they will be provided a placebo capsule containing only glycerin.
Assessment \& outcome measured: Blood samples will be taken from each subject at baseline (0 hours) and after 1-4 hours of the placebo administration. Aggregation of their platelets will be assessed as previously described (see references 1-4), in order to evaluate the postprandial effects of this supplement on platelet aggregation.
Other blood coagulation parameters will also be evaluated, such as prothrombin time, fibrinogen, Activated partial thromboplastin time Plasma lipid profile (levels of plasma Total Cholesterol, LDL, HDL and Triglycerides) and serum CRP levels will also be assessed.
Placebo food supplement capsule
Postprandial unaffected platelet activation/aggregation in subjects, after the food supplement capsule consumption
Interventions
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Food supplement capsules containing Salmon-Polar Lipids
Postprandial decreased Platelet activation/aggregation in subjects, after the food supplement capsule consumption
Placebo food supplement capsule
Postprandial unaffected platelet activation/aggregation in subjects, after the food supplement capsule consumption
Eligibility Criteria
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Inclusion Criteria
* Have their dietary intake of fish to be within normal range (1-2 portions per week).
Exclusion Criteria
* Are currently taking medication and/or dietary supplements
* Have blood clotting disorders or dislipidemia
18 Years
ALL
Yes
Sponsors
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University of Limerick
OTHER
Responsible Party
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Ioannis Zabetakis
Principal Investigator
Principal Investigators
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Ioannis Zabetakis, Dr
Role: PRINCIPAL_INVESTIGATOR
University of Limerick
Locations
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Department of Biological Sciences
Limerick, Co. Limerick, Ireland
Countries
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References
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Tsoupras A, Lordan R, Demuru M, Shiels K, Saha SK, Nasopoulou C, Zabetakis I. Structural Elucidation of Irish Organic Farmed Salmon (Salmo salar) Polar Lipids with Antithrombotic Activities. Mar Drugs. 2018 May 23;16(6):176. doi: 10.3390/md16060176.
Nasopoulou C, Tsoupras AB, Karantonis HC, Demopoulos CA, Zabetakis I. Fish polar lipids retard atherosclerosis in rabbits by down-regulating PAF biosynthesis and up-regulating PAF catabolism. Lipids Health Dis. 2011 Nov 16;10:213. doi: 10.1186/1476-511X-10-213.
Tsantila N, Tsoupras AB, Fragopoulou E, Antonopoulou S, Iatrou C, Demopoulos CA. In vitro and in vivo effects of statins on platelet-activating factor and its metabolism. Angiology. 2011 Apr;62(3):209-18. doi: 10.1177/0003319710375089. Epub 2010 Aug 29.
Xanthopoulou MN, Kalathara K, Melachroinou S, Arampatzi-Menenakou K, Antonopoulou S, Yannakoulia M, Fragopoulou E. Wine consumption reduced postprandial platelet sensitivity against platelet activating factor in healthy men. Eur J Nutr. 2017 Jun;56(4):1485-1492. doi: 10.1007/s00394-016-1194-0. Epub 2016 Mar 2.
Other Identifiers
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IP 2017 0518
Identifier Type: -
Identifier Source: org_study_id