Cardiovascular Diseases
Conditions
Brief summary
This study aims to evaluate antithrombotic activities of novel yoghurt drink in healthy adult volunteers
Detailed description
This randomized controlled, double-blinded crossover study aims to investigate the antithrombotic activities of a novel yoghurt drink in healthy adult volunteers. It is anticipated that the novel drink containing beneficial polar lipids will reduce platelet aggregation in participants and consequently decrease the onset of cardiovascular disease. In Phase I, the subjects will provide blood samples after overnight fasting and then take either a yoghurt drink (YD) or placebo (that does not contain polar lipids) daily for 4 weeks. Following this period, they will again provide blood samples. Then, after a 2-week washout period in which the subjects do not take any yoghurt or placebo drink , Phase II of the clinical trial will commence. This is the crossover phase in which subjects who took YD will now be given a placebo drink, and vice versa, over 4 weeks. A total of 80 blood samples will be collected for analysis.
Interventions
DIETARY_SUPPLEMENTNovel yogurt drink
Novel ovine yogurt drink containing polar lipids
OTHERPlacebo Drink
Placebo drink (skimmed milk)
Sponsors
University of Limerick
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults
Exclusion criteria
* Volunteers need to be off medication and off any dietary supplements. * Subjects must not have any blood clotting disorders or dyslipidaemia. * Dairy intake needs to be within a normal range of 1-2 portions a week. * Unwilling to follow the study requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Platelet aggregation of PRP samples in the presence of PAF | Participants' platelet activity will be assessed for up to roughly 6 months through study completion | Platelet aggregation of participants' platelet-rich plasma samples (PRP) in the presence of the platelet agonist PAF will be assessed, using EC50 as a parameter. |
| Screening of plasma levels of cholesterol ( PL, LDL, HDL, VLDL). | The outcomes of this testing will be assessed for up to roughly 6 months through study completion. | Platelet-rich plasma (PRP) levels of cholesterol ( PL, LDL, HDL, VLDL levels) will be assessed. |
| Screening plasma levels of inflammatory markers. | The outcomes of this testing will be assessed for up to roughly 6 months through study completion. | Platelet-rich plasma levels of the inflammatory markers (IL-6, CRP. TNF-α, VEGF, VCAM-1 and PAFR) will all be screened. |
| Screening plasma levels of triglycerides. | The outcomes of this testing will be assessed for up to roughly 6 months through study completion. | PRP levels of triglycerides will also be screened. |
Countries
Ireland
Outcome results
None listed