Antithrombotic Activities of a Novel Yoghurt Drink: a Postprandial Study

NCT ID: NCT05290883

Last Updated: 2022-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-14

Study Completion Date

2021-08-25

Brief Summary

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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

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Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group A: Yoghurt drink (polar lipid) intervention

Group Type EXPERIMENTAL

Novel yoghurt drink containing Polar Lipids

Intervention Type DIETARY_SUPPLEMENT

Postprandial decreased platelet activation/aggregation in subjects, after the yoghurt drink consumption

Interventions

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Novel yoghurt drink containing Polar Lipids

Postprandial decreased platelet activation/aggregation in subjects, after the yoghurt drink consumption

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Limerick

OTHER

Sponsor Role lead

Responsible Party

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Ioannis Zabetakis

Senior Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Limerick

Limerick, , Ireland

Site Status

Countries

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Ireland

References

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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.

Reference Type BACKGROUND
PMID: 30619728 (View on PubMed)

Related Links

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Other Identifiers

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S&E REC No. 2022_01_01_S&E

Identifier Type: -

Identifier Source: org_study_id

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