Antithrombotic Activities of a Novel Yogurt Drink

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

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Dietary supplement: Novel yogurt drink; Other: Placebo Drink

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Limerick, Ireland
    • University of Limerick

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Supplement Group; 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; Novel ovine yogurt drink containing polar lipids
PLACEBO_COMPARATOR: Placebo Group; 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; Placebo drink (skimmed milk)

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of Limerick

Publications and helpful links

General Publications

• Tsoupras A, Zabetakis I, Lordan R. Platelet aggregometry assay for evaluating the effects of platelet agonists and antiplatelet compounds on platelet function in vitro. MethodsX. 2018 Dec 26;6:63-70. doi: 10.1016/j.mex.2018.12.012. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2022
• Primary Completion (ACTUAL): September 30, 2022
• Study Completion (ACTUAL): September 30, 2022

Study Registration Dates

• First Submitted: March 4, 2022
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (ACTUAL): April 8, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 2022_01_01_S&E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No