Antithrombotic Activities of a Novel Yoghurt Drink: a Postprandial Study
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable cardiovascular-diseases
Started May 2021
Shorter than P25 for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2021
CompletedFirst Submitted
Initial submission to the registry
March 4, 2022
CompletedFirst Posted
Study publicly available on registry
March 22, 2022
CompletedNovember 7, 2022
November 1, 2022
2 months
March 4, 2022
November 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (1)
Group A: Yoghurt drink (polar lipid) intervention
EXPERIMENTALInterventions
Postprandial decreased platelet activation/aggregation in subjects, after the yoghurt drink consumption
Eligibility Criteria
You may qualify if:
- Healthy subjects need to have their dietary and dairy intake within the range \[1-2 serves per week\]
You may not qualify if:
- Subjects will be excluded from the study if they are
- Under medication and intake of dietary supplements
- Treatment for blood clotting disorders or dyslipidaemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Limerick
Limerick, V94 T9PX, Ireland
Related 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.
PMID: 30619728BACKGROUND
Related Links
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Lecturer
Study Record Dates
First Submitted
March 4, 2022
First Posted
March 22, 2022
Study Start
May 14, 2021
Primary Completion
July 18, 2021
Study Completion
August 25, 2021
Last Updated
November 7, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share