Antithrombotic Activities of a Novel Yogurt Drink

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05318911
• Other study ID #: 2022_01_01_S&E
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2022
• Source: University of Limerick
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Novel yogurt drink
Novel ovine yogurt drink containing polar lipids

Other:
• Placebo Drink
Placebo drink (skimmed milk)

Locations

Country	Name	City	State
Ireland	University of Limerick	Limerick

Sponsors (1)

Lead Sponsor	Collaborator
University of Limerick

Country where clinical trial is conducted

Ireland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	Screening plasma levels of inflammatory markers.	Platelet-rich plasma levels of the inflammatory markers (IL-6, CRP. TNF-a, 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.
Primary	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.