Antithrombotic Activities of a Novel Yogurt Drink

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Dietary Supplement: Novel yogurt drink; Other: Placebo Drink

• Registration Number: NCT05318911
• Lead Sponsor: University of Limerick

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.

Study Timeline

• Study First Submitted: 2022-03-04
• Study First Submitted QC: 2022-04-07
• Study First Posted: 2022-04-08
• Study Start: 2022-05-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Supplement Group	Novel yogurt drink	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.
Placebo Group	Placebo Drink	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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

University of Limerick; 🇮🇪 Limerick, Ireland