Antithrombotic Activities of a Novel Yoghurt Drink: a Postprandial Study

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Dietary Supplement: Novel yoghurt drink containing Polar Lipids

• Registration Number: NCT05290883
• Lead Sponsor: University of Limerick

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-14
• Primary Completion: 2021-07-18
• Study Completion: 2021-08-25
• Study First Submitted: 2022-03-04
• Study First Submitted QC: 2022-03-21
• Study First Posted: 2022-03-22
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A: Yoghurt drink (polar lipid) intervention	Novel yoghurt drink containing Polar Lipids	-

Primary Outcome Measures

Name	Time	Method
An investigation of anti-platelet or antithrombotic effect of novel yoghurt drink by platelet aggregometry	0 mins (preprandially) to 240 mins (postprandially)	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).

Trial Locations

Locations (1)

University of Limerick; 🇮🇪 Limerick, Ireland