Antithrombotic Activities of a Novel Yogurt Drink

Study Overview
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Brief Summary
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This study aims to evaluate antithrombotic activities of novel yoghurt drink in healthy adult volunteers

Detailed Description
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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.

Official Title
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Antithrombotic Activities of a Novel Yogurt Drink: a Dietary Intervention Study

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Dietary Supplement: Novel yogurt drink
* Other: Placebo Drink


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Supplement Group<br>10 participants will provide baseline blood samples after overnight fasting, on day 0 of the study. Following this they will initially consume 200 mL of novel yogurt drink per day for a period of 28 days. Then, after a 2-week washout period in which the subjects do not take any yoghurt 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. | Dietary Supplement: Novel yogurt drink<br>* Novel ovine yogurt drink containing polar lipids<br>|
| Placebo Comparator: Placebo Group<br>10 participants will provide baseline blood samples after overnight fasting, on day 0 of the study. Following this they will initially consume 200 mL of placebo drink per day for a period of 28 days. Then, after a 2-week washout period in which the subjects do not take any 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. | Other: Placebo Drink<br>* Placebo drink (skimmed milk)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | The outcomes of this testing will be assessed for up to roughly 6 months through study completion. |