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

University of Limerick

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Dietary Supplement: Placebo food supplement capsule; Dietary Supplement: Food supplement capsules containing Salmon-Polar Lipids

Study type: Interventional

Funder types: Other

Identifiers

NCT03603769

IP 2017 0518

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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6 participants in 2 patient groups, including a placebo group

Group A: Food Supplement (Salmon Polar Lipids) Intervention

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Food supplement capsules containing Salmon-Polar Lipids

Group B: Consumption of Placebo Comparator

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo food supplement capsule