Antithrombotic Activities of a Novel Yoghurt Drink: a Postprandial Study

Cardiovascular Diseases Clinical Trial

Official title:

Antithrombotic Activities of a Novel Yoghurt Drink: a Postprandial Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05290883
• Other study ID #: S&E REC No. 2022_01_01_S&E
• Status: Completed
• Phase: N/A
• Start date: May 14, 2021
• Est. completion date: August 25, 2021

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: August 25, 2021
• Est. primary completion date: July 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Novel yoghurt drink containing Polar Lipids
Postprandial decreased platelet activation/aggregation in subjects, after the yoghurt drink consumption

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	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)

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