Clinical trial NCT03603769: In Vitro And Ex Vivo Anti-Inflammatory Activities Of Salmon Polar Lipids
Official title: In Vitro And Ex Vivo Anti-Inflammatory Activities Of Salmon Polar Lipids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: University of Limerick
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Each subject will participate in five daily trials on 5 separate days, at least 2 weeks apart.

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.
Primary purpose: PREVENTION

Brief summary: The aim of this project is to study the effects of a new-developed food-supplement that contains bioactive polar lipids derived from organic farmed Irish salmon for the beneficial promotion of cardiovascular health. The health claims that will be formulated for this nutraceutical are based on EFSA guidelines "The scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health" and in particular paragraph 5.4, "Claims on reduced platelet aggregation" "Platelet hyperactivity and hypercoagulability states are more commonly observed in subjects with cardiovascular (CV) risk factors. Healthy subjects at very low risk of CV disease normally have non-activated circulating platelets. Decreasing platelet aggregation in subjects with platelet activation during sustained exposure to the food/constituent (e.g. four weeks) would be a beneficial physiological effect".

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.


Eligibility criteria: Inclusion Criteria:

Subjects need to:

* Have their dietary intake of fish to be within normal range (1-2 portions per week).

Exclusion Criteria:

Subjects will be excluded if they:

* Are currently taking medication and/or dietary supplements
* Have blood clotting disorders or dislipidemia

Primary outcomes:
measure: Postprandial effect of Supplement/placebo on human platelet aggregation induced by Platelet Activating Factor (PAF)
timeFrame: 2 Months
Secondary outcomes:
measure: Postprandial effect of Supplement/placebo on human platelet aggregation induced by Thrombin
timeFrame: 2 Months
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: Department of Biological Sciences
state: Co. Limerick
Study officials:
affiliation: University of Limerick
name: Ioannis Zabetakis, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.