Antithrombotic Activities of a Novel Yogurt Drink

University of Limerick20 enrolled

Overview

This study aims to evaluate antithrombotic activities of novel yoghurt drink in healthy adult volunteers

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Cardiovascular Diseases

Interventions

Novel yogurt drinkDIETARY_SUPPLEMENT

Novel ovine yogurt drink containing polar lipids

Placebo DrinkOTHER

Placebo drink (skimmed milk)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Limerick

Limerick, Ireland

Outcomes

Primary Outcomes

Platelet aggregation of PRP samples in the presence of PAF

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.

Time frame: Participants' platelet activity will be assessed for up to roughly 6 months through study completion

Screening of plasma levels of cholesterol ( PL, LDL, HDL, VLDL).

Platelet-rich plasma (PRP) levels of cholesterol ( PL, LDL, HDL, VLDL levels) will be assessed.

Time frame: The outcomes of this testing will be assessed for up to roughly 6 months through study completion.

Screening plasma levels of inflammatory markers.

Platelet-rich plasma levels of the inflammatory markers (IL-6, CRP. TNF-α, VEGF, VCAM-1 and PAFR) will all be screened.

Time frame: The outcomes of this testing will be assessed for up to roughly 6 months through study completion.

Screening plasma levels of triglycerides.

PRP levels of triglycerides will also be screened.

Time frame: The outcomes of this testing will be assessed for up to roughly 6 months through study completion.

Data from ClinicalTrials.gov

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