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Completed

NCT Number: NCT03603769

In Vitro And Ex Vivo Anti-Inflammatory Activities Of Salmon Polar Lipids

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.

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Key information

Conditions

Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Biological Sciences

Limerick, Co. Limerick, V94 T9PX, Ireland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Food supplement capsules containing Salmon-Polar Lipids

Dietary Supplement

Postprandial decreased Platelet activation/aggregation in subjects, after the food supplement capsule consumption

Placebo food supplement capsule

Dietary Supplement

Postprandial unaffected platelet activation/aggregation in subjects, after the food supplement capsule consumption

Primary outcomes

  1. Postprandial effect of Supplement/placebo on human platelet aggregation induced by Platelet Activating Factor (PAF)

    Time frame: 2 Months

    Bio-assays on platelets will be assessed as previously described. Briefly:

    Standard PAF dissolved in BSA will have final concentrations 2.6e-8 - 2.6e-5 mol/L when testing into a Chronolog-490 two channel turbidimetric platelet aggregometer. The maximum reversible or the minimum irreversible PAF-induced platelet aggregation is determined as the 100% aggregation, and then various PAF concentrations are added, so as to achieve aggregations between 20% and 80% aggregation, which are of linear response to the added PAF concentration. The EC50 value that accounts for the PAF concentration (mol/L) inducing 50% aggregation of human platelets will be calculated by the equation derived from this linear curve. Results will be expressed as percentage change of EC50 on 1, 2, 3 and 4 hours of the food supplement/placebo administration, compared with baseline (0 hours)

Secondary outcomes

  1. Postprandial effect of Supplement/placebo on human platelet aggregation induced by Thrombin

    Time frame: 2 Months

    Bio-assays on platelets will be assessed as previously described. Briefly:

    Standard active thrombin dissolved in saline will have final concentrations 0.01 - 1.0 IU/mL when testing into a Chronolog-490 two channel turbidimetric platelet aggregometer. The maximum reversible or the minimum irreversible Thrombin-induced platelet aggregation is determined as the 100% aggregation, and then various Thrombin concentrations are added, so as to achieve aggregations between 20% and 80% aggregation, which are of linear response to the added Thrombin concentration. The EC50 value that accounts for the Thrombin concentration (IU/mL) inducing 50% aggregation of human platelets will be calculated by the equation derived from this linear curve. Results will be expressed as percentage change of EC50 on 1, 2, 3 and 4 hours of the food supplement/placebo administration, compared with baseline (0 hours).

Sponsors and collaborators

Lead sponsor

University of Limerick

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jul 27, 2018
Registry last updated
Dec 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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