Antithrombotic Activities of a Novel Yoghurt Drink: a Postprandial Study

The project aims to investigate the antithrombotic activity of the novel yoghurt drink enriched with polar lipids derived from ovine milk. The health claims the formulated novel or functional food on EFSA guidelines "The scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health" and in a particular paragraph 5.4, "Claims on reduced platelet aggregation" "Platelet hyperactivity and hypercoagulability states are more commonly observed in subjects with cardiovascular (CV) risk factors. Healthy subjects or participants at very low risk of CV disease normally have non-activated circulating platelets. Reducing platelet aggregation in subjects with platelet activation during sustained exposure to the food/constituent (e.g., four weeks) would be a beneficial physiological effect".

Within this investigation, the postprandial effects of this novel yoghurt drink against platelet aggregation are going to be studied ex vivo in blood from healthy human subjects as described in previously established procedures.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Dietary supplement: Novel yoghurt drink containing Polar Lipids

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Limerick, Ireland, V94 T9PX
    • 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 subjects need to have their dietary and dairy intake within the range [1-2 serves per week]

Exclusion Criteria:

• Subjects will be excluded from the study if they are

  • Under medication and intake of dietary supplements
  • Treatment for blood clotting disorders or dyslipidaemia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: Yoghurt drink (polar lipid) intervention	Dietary supplement: Novel yoghurt drink containing Polar Lipids; Postprandial decreased platelet activation/aggregation in subjects, after the yoghurt drink consumption

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
An investigation of anti-platelet or antithrombotic effect of novel yoghurt drink by platelet aggregometry	An investigation of anti-platelet or antithrombotic effect of novel yoghurt drink by platelet aggregometry will be carried out. The postprandial effect of novel yoghurt drink will be studied by using a platelet aggregation method as per literature. The antithrombotic effect of yoghurt drink lipids will be studied, using PAF and TRAP as platelet aggregation mediators. The investigation will be based on the study-specific platelet aggregometry analysis. Subjects will come to the lab after overnight fasting and they will be provided yoghurt drink (200mL); the activation of their platelets will be monitored over a period of 4 hours (0 to 4 hours study with 1 hour check points).	0 mins (preprandially) to 240 mins (postprandially)

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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2021
• Primary Completion (Actual): July 18, 2021
• Study Completion (Actual): August 25, 2021

Study Registration Dates

• First Submitted: March 4, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 22, 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: S&E REC No. 2022_01_01_S&E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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