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Antithrombotic Activities of a Novel Yoghurt Drink: a Postprandial Study

Sponsor
University of Limerick (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05290883
Collaborator
(none)
5
Enrollment
1
Location
1
Arm
2.4
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Novel yoghurt drink containing Polar Lipids
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
5 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Antithrombotic Activities of a Novel Yoghurt Drink: a Postprandial Study
Anticipated Study Start Date :
May 14, 2022
Anticipated Primary Completion Date :
Jul 18, 2022
Anticipated Study Completion Date :
Jul 25, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Limerick Limerick Ireland V94 T9PX

Sponsors and Collaborators

  • University of Limerick

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Ioannis Zabetakis, Senior Lecturer, University of Limerick
ClinicalTrials.gov Identifier:
NCT05290883
Other Study ID Numbers:
  • S&E REC No. 2022_01_01_S&E
First Posted:
Mar 22, 2022
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cardiovascular Diseases

Study Results

No Results Posted as of Mar 31, 2022