Platelet ThrombusNCT03866265
Anti-Inflammatory and Anti-Coagulant Effects of Salmon Polar Lipids
A study testing Food Grade Extract of Salmon Polar Lipids (FGE-Salmon-PLs) in people with Platelet Thrombus, run by University of Limerick at 1 site in Ireland.
Trial 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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Platelet Thrombus
- What is being tested?
- Food Grade Extract of Salmon Polar Lipids (FGE-Salmon-PLs)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIreland
- Study dates
- 1 Apr 2019to 15 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The selection criteria of the subjects will be as follows:
- they need to be off medication and off intake of dietary supplements
- they need to have no blood clotting disorders or dyslipidaemia and
Who cannot join
- Subjects with clotting disorders, dyslipidemia or being on medication (i.e. statins) or other supplements during the study will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anti-Inflammatory and Anti-Coagulant Effects of a Novel Food Grade Salmon Polar Lipids Supplement
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.
Read more
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).
Read the 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
- Being tested
- Food Grade Extract of Salmon Polar Lipids (FGE-Salmon-PLs), Placebo
- Keywords
- Platelet Sensitivity, PAF, Thrombin, Salmon Polar Lipids, anti-inflammatory, anti-coagulant, platelet aggregation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Grade Extract of Salmon Polar Lipids (FGE-Salmon-PLs)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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Supplement Group | Active comparator | 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) Receives: Dietary Supplement: Food Grade Extract of Salmon Polar Lipids (FGE-Salmon-PLs) |
| Placebo Group | Placebo comparator | 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) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on the Platelet Sensitivity against PAF
Platelet sensitivity against PAF of platelet rich plasma of each blood sample will be determined by the % observed change of the EC50 value of PAF-induced platelet aggregation before and after administration of either the FGE-Salmon-PLs food supplement or the placebo capsules.
Measured: Tests will be conducted just after blood collection for each blood sample and the outcomes measured will be assessed up to 6 months, for which the data will be reported through study completion
Effect on the Platelet Sensitivity against Thrombin
Platelet sensitivity against Thrombin of platelet rich plasma of each blood sample will be determined by the % observed change of the EC50 value of Thrombin-induced platelet aggregation before and after administration of either the FGE-Salmon-PLs food supplement or the placebo capsules.
Measured: Tests will be conducted just after blood collection for each blood sample and the outcomes measured will be assessed up to 6 months, for which the data will be reported through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start1 Apr 2019
- Primary completion15 Nov 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet ThrombusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Blood samples will be taken at day 0 from all Subjects. 10 of them will be administered for 28 days a food supplement capsule (0.125 g of FGE-Salmon-PLs) per day, while the other 10 will be administered a placebo capsule (0.125 g of glycerine) per day, in a double blind and randomized way. After 28-days, blood samples will be collected from all Subjects. No administration of any kind of capsules will follow for 14 days for all Subjects. After this 14-days period, blood samples will be collected from all Subjects Then, in a crossover design each participant initially on supplement will now be administered the placebo capsules, while likewise each participant initially on placebo will now be administered the supplement capsules for 28 days. After this new 28-days period, blood samples will be collected from all Subjects. All collected blood samples from each participant will be tested for their platelet sensitivity against both PAF and Thrombin induced platelet aggregation.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ioannis Zabetakis, University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866265
- Sponsor's protocol ID
- DeptBiolScULimerick
- Status last verified
- Dec 2019
- First submitted
- 1 Mar 2019
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Inflammatory and Anti-Coagulant Effects of a Novel Food Grade Salmon Polar Lipids Supplement
- ClinicalTrials.gov ID
- NCT03866265
- Acronym / sponsor ID
- DeptBiolScULimerick
- Conditions
- Platelet Thrombus
- Keywords
- Platelet Sensitivity, PAF, Thrombin, Salmon Polar Lipids, anti-inflammatory, anti-coagulant, platelet aggregation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Blood samples will be taken at day 0 from all Subjects. 10 of them will be administered for 28 days a food supplement capsule (0.125 g of FGE-Salmon-PLs) per day, while the other 10 will be administered a placebo capsule (0.125 g of glycerine) per day, in a double blind and randomized way. After 28-days, blood samples will be collected from all Subjects. No administration of any kind of capsules will follow for 14 days for all Subjects. After this 14-days period, blood samples will be collected from all Subjects Then, in a crossover design each participant initially on supplement will now be administered the placebo capsules, while likewise each participant initially on placebo will now be administered the supplement capsules for 28 days. After this new 28-days period, blood samples will be collected from all Subjects. All collected blood samples from each participant will be tested for their platelet sensitivity against both PAF and Thrombin induced platelet aggregation.
| Arm | Type | Receives |
|---|---|---|
| Supplement Group | Active comparator | Dietary Supplement: Food Grade Extract of Salmon Polar Lipids (FGE-Salmon-PLs)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) |
| Placebo Group | Placebo comparator | Other: Placebo10 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- The selection criteria of the subjects will be as follows:
Key exclusion criteria (1 listed)
- Subjects with clotting disorders, dyslipidemia or being on medication (i.e. statins) or other supplements during the study will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Supplement Group |
| PlaceboEach 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. | Other | Placebo Group |
Primary outcome
Effect on the Platelet Sensitivity against PAF
Time frame: Tests will be conducted just after blood collection for each blood sample and the outcomes measured will be assessed up to 6 months, for which the data will be reported through study completion
Platelet sensitivity against PAF of platelet rich plasma of each blood sample will be determined by the % observed change of the EC50 value of PAF-induced platelet aggregation before and after administration of either the FGE-Salmon-PLs food supplement or the placebo capsules.
Effect on the Platelet Sensitivity against Thrombin
Time frame: Tests will be conducted just after blood collection for each blood sample and the outcomes measured will be assessed up to 6 months, for which the data will be reported through study completion
Platelet sensitivity against Thrombin of platelet rich plasma of each blood sample will be determined by the % observed change of the EC50 value of Thrombin-induced platelet aggregation before and after administration of either the FGE-Salmon-PLs food supplement or the placebo capsules.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Platelet Thrombus
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Active, not recruiting
Thromboelastography With Platelet Mapping to Guide Antiplatelet Therapy After Lower Extremity Revascularization
Thrombosis, Arterial Occlusive Diseases
Not yet recruitingPhase 4
Investigating a Personalized Approach to Anti-Platelet Therapy
High Risk Bleeding
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
Not yet recruitingObservational study
Comparison of Thrombin Generation, Platelet Activation and Aggregation Profiles in Patients With Sickle Cell Disease Depending on Their SS or SC Genotype (DrepAgreg)
Sickle Cell Disease, Venous Thromboembolism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Grade Extract of Salmon Polar Lipids (FGE-Salmon-PLs) in people with Platelet Thrombus, run by University of Limerick at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on the Platelet Sensitivity against PAF (time frame: Tests will be conducted just after blood collection for each blood sample and the outcomes measured will be assessed up to 6 months, for which the data will be reported through study completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2019.