Antithrombotic Activities of a Novel Yogurt Drink

NCT ID: NCT05318911

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2022-09-30

Brief Summary

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This study aims to evaluate antithrombotic activities of novel yoghurt drink in healthy adult volunteers

Detailed Description

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This randomized controlled, double-blinded crossover study aims to investigate the antithrombotic activities of a novel yoghurt drink in healthy adult volunteers. It is anticipated that the novel drink containing beneficial polar lipids will reduce platelet aggregation in participants and consequently decrease the onset of cardiovascular disease.

In Phase I, the subjects will provide blood samples after overnight fasting and then take either a yoghurt drink (YD) or placebo (that does not contain polar lipids) daily for 4 weeks. Following this period, they will again provide blood samples. Then, after a 2-week washout period in which the subjects do not take any yoghurt or placebo drink , Phase II of the clinical trial will commence. This is the crossover phase in which subjects who took YD will now be given a placebo drink, and vice versa, over 4 weeks. A total of 80 blood samples will be collected for analysis.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Supplement Group

10 participants will provide baseline blood samples after overnight fasting, on day 0 of the study. Following this they will initially consume 200 mL of novel yogurt drink per day for a period of 28 days.

Then, after a 2-week washout period in which the subjects do not take any yoghurt drink , Phase II of the clinical trial will commence. This is the crossover phase in which subjects who took YD will now be given a placebo drink, and vice versa, over 4 weeks. A total of 80 blood samples will be collected for analysis.

Group Type ACTIVE_COMPARATOR

Novel yogurt drink

Intervention Type DIETARY_SUPPLEMENT

Novel ovine yogurt drink containing polar lipids

Placebo Group

10 participants will provide baseline blood samples after overnight fasting, on day 0 of the study. Following this they will initially consume 200 mL of placebo drink per day for a period of 28 days.

Then, after a 2-week washout period in which the subjects do not take any placebo drink , Phase II of the clinical trial will commence. This is the crossover phase in which subjects who took YD will now be given a placebo drink, and vice versa, over 4 weeks. A total of 80 blood samples will be collected for analysis.

Group Type PLACEBO_COMPARATOR

Placebo Drink

Intervention Type OTHER

Placebo drink (skimmed milk)

Interventions

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Novel yogurt drink

Novel ovine yogurt drink containing polar lipids

Intervention Type DIETARY_SUPPLEMENT

Placebo Drink

Placebo drink (skimmed milk)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy adults

Exclusion Criteria

* Volunteers need to be off medication and off any dietary supplements.
* Subjects must not have any blood clotting disorders or dyslipidaemia.
* Dairy intake needs to be within a normal range of 1-2 portions a week.
* Unwilling to follow the study requirements.
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

Head of Department of Biological Sciences

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)

Other Identifiers

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2022_01_01_S&E

Identifier Type: -

Identifier Source: org_study_id

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