Anti-Inflammatory and Anti-Coagulant Effects of Salmon Polar Lipids

NCT ID: NCT03866265

Last Updated: 2019-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2019-12-15

Brief Summary

Inflammation is a normal immune response to tissue healing. However, uncontrolled and unresolved inflammation can initiate and further induce several chronic manifestations that contribute to chronic disorders such as atherosclerosis and cardiovascular disease (CVD). A 'cross-talk' between platelets, endothelial cells and leukocytes, accompanied by activation and aggregation of platelets, contribute to inflammation-related atherogenic, atherosclerotic and athero-thrombotic events.

Platelet Activating Factor (PAF) and Thrombin are the most potent platelet agonists inducing platelet activation and aggregation that are also implicated in the patho-physiology of platelets and endothelium and thus in inflammation-related chronic disorders. Therefore, the inhibition of PAF and Thrombin related pathways of platelet aggregation, coagulation and inflammation provide a potential therapeutic strategy for anti-platelet, anti-coagulation and suppression of inflammatory responses in CVDs and other chronic disorders.

The investigators have previously reported bio-active lipid molecules with strong anti-PAF and anti-Thrombin effects to be present in natural, non-toxic food, microorganisms, plants and especially in several marine sources. The plethora of in vitro beneficial bio-activities of marine polar lipids (PLs) against atherosclerosis and CVDs indicate therapeutic potential. Recently, the investigators have also demonstrated that PLs extracted from Irish, organic farmed salmon (Salmo salar) display strong in vitro anti-thrombotic effects against platelet aggregation, bio-activities that were related to inhibitory effect against PAF and Thrombin pathways.

The present study investigates the putative anti-platelet effects in healthy human subjects following ingestion of a novel supplement containing food-grade extracts of bio-active salmon polar lipids (FGE-Salmon-PLs).

The study has a double blind randomized cross-over placebo-controlled design in healthy subjects.

Each Subject will be administrated the FGE-Salmon-PLs Food Supplement capsules for 28 days (a capsule containing 0.125 g of FGE-Salmon-PLs per day) and platelet sensitivity against both PAF and Thrombin will be tested in blood samples of each subject just before and after the supplement administration. The same tests will be conducted in blood samples of each participant in a crossover design before and after 28 days of placebo capsules administration (a capsule containing 0.125 g of glycerin per day).

Detailed Description

The present study investigates the putative anti-platelet effects in healthy human subjects (N=20) following ingestion of a novel supplement containing food-grade extracts of bio-active salmon polar lipids (FGE-Salmon-PLs).

The study has a double blind randomized cross-over placebo-controlled design in healthy subjects.

After appropriate screening, 20 of the recruited subjects will provide baseline blood samples and then 10 of them will be initially administered a food supplement capsule (containing 0.125 g of FGE-Salmon-PLs) per day for a period of 28 days, while another 10 of them will initially be administered a placebo capsule (containing 0.125 g of glycerin) per day, in a double blind and randomized way.

After the period of 28 days, each participant will provide blood samples at the 29th day.

Then a washout period of 14 days will follow, in which each participant will not be administered any kind of supplements or placebo capsules.

After this washout period of 14 days, each participant will provide again new baseline blood samples and then in a crossover design the participants that were initially administered the food supplement will now be administered the placebo capsules for 28 days (a placebo capsule per day), while likewise the participants that were initially administered the supplement capsules will now be administered the food supplement capsules for 28 days.

After this new period of 28 days, each participant will provide again blood samples at the new 29th day.

Plasma reach in platelets of all blood samples from each participant, before and after each kind of administration (of either placebo or supplement capsules), will be tested for their platelet sensitivity against both PAF and Thrombin induced platelet aggregation.

Conditions

Platelet Thrombus

Keywords

Platelet Sensitivity; PAF; Thrombin; Salmon Polar Lipids; anti-inflammatory; anti-coagulant; platelet aggregation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Supplement Group

10 Subjects will provide baseline blood samples at day 0. Just after they will be initially administered a food supplement capsule (containing 0.125 g of FGE-Salmon-PLs) per day for a period of 28 days.

After the period of 28 days, each participant will provide blood samples at the 29th day.

Then a washout period of 14 days will follow, in which each participant will not be administered any kind of capsules.

After this washout period of 14 days, each participant will provide again new baseline blood samples and then in a crossover design the participants of this group that were initially administered the food supplement will now be administered the placebo capsules for 28 days (a placebo capsule per day)

Group Type: ACTIVE_COMPARATOR

Food Grade Extract of Salmon Polar Lipids (FGE-Salmon-PLs)

Intervention Type: DIETARY_SUPPLEMENT

Each participant will be administered per day a capsule of the FGE-Salmon-PLs food supplement (containing 0.125 g of FGE-Salmon-PLs) for a period of 28 days in a double blind randomized, crossover and placebo-controlled design.

Placebo Group

10 Subjects will provide baseline blood samples at day 0. Just after they will be initially administered a placebo capsule (containing 0.125 g of glycerin) per day for a period of 28 days.

After the period of 28 days, each participant will provide blood samples at the 29th day.

Then a washout period of 14 days will follow, in which each participant will not be administered any kind of capsules.

After this washout period of 14 days, each participant will provide again new baseline blood samples and then in a crossover design the participants of this group that were initially administered the placebo capsules will now be administered the food supplement capsules for 28 days (a food supplement capsule per day)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Each participant will be administered per day a placebo capsule (containing 0.125 g of glycerin) for a period of 28 days in a double blind randomized, crossover design.

Interventions

Food Grade Extract of Salmon Polar Lipids (FGE-Salmon-PLs)

Each participant will be administered per day a capsule of the FGE-Salmon-PLs food supplement (containing 0.125 g of FGE-Salmon-PLs) for a period of 28 days in a double blind randomized, crossover and placebo-controlled design.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Each participant will be administered per day a placebo capsule (containing 0.125 g of glycerin) for a period of 28 days in a double blind randomized, crossover design.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• The selection criteria of the subjects will be as follows:

1. they need to be off medication and off intake of dietary supplements

2. they need to have no blood clotting disorders or dyslipidaemia and

Exclusion Criteria

Subjects with clotting disorders, dyslipidemia or being on medication (i.e. statins) or other supplements during the study will be excluded.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Limerick

OTHER

Sponsor Role: lead

Responsible Party

Ioannis Zabetakis

Head of the Department of Biological Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Limerick

Limerick, Co. Limerick, Ireland

Countries

Ireland

Other Identifiers

DeptBiolScULimerick

Identifier Type: -

Identifier Source: org_study_id