Cardiovascular Diseases
Conditions
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.
Interventions
DIETARY_SUPPLEMENTFood supplement capsules containing Salmon-Polar Lipids
Postprandial decreased Platelet activation/aggregation in subjects, after the food supplement capsule consumption
DIETARY_SUPPLEMENTPlacebo food supplement capsule
Postprandial unaffected platelet activation/aggregation in subjects, after the food supplement capsule consumption
Sponsors
University of Limerick
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
A placebo capsule (glycerine only, with no SPL)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial effect of Supplement/placebo on human platelet aggregation induced by Platelet Activating Factor (PAF) | 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
| Measure | Time frame | Description |
|---|---|---|
| Postprandial effect of Supplement/placebo on human platelet aggregation induced by Thrombin | 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). |
Countries
Ireland
Outcome results
None listed