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Completed

NCT Number: NCT05318911

Antithrombotic Activities of a Novel Yogurt Drink

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

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Key information

Conditions

Cardiovascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Limerick

Limerick, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Novel yogurt drink

Dietary Supplement

Novel ovine yogurt drink containing polar lipids

Placebo drink

Other

Placebo drink (skimmed milk)

Primary outcomes

  1. Platelet aggregation of PRP samples in the presence of PAF

    Time frame: Participants' platelet activity will be assessed for up to roughly 6 months through study completion

    Platelet aggregation of participants' platelet-rich plasma samples (PRP) in the presence of the platelet agonist PAF will be assessed, using EC50 as a parameter.

  2. Screening of plasma levels of cholesterol ( PL, LDL, HDL, VLDL).

    Time frame: The outcomes of this testing will be assessed for up to roughly 6 months through study completion.

    Platelet-rich plasma (PRP) levels of cholesterol ( PL, LDL, HDL, VLDL levels) will be assessed.

  3. Screening plasma levels of inflammatory markers.

    Time frame: The outcomes of this testing will be assessed for up to roughly 6 months through study completion.

    Platelet-rich plasma levels of the inflammatory markers (IL-6, CRP. TNF-α, VEGF, VCAM-1 and PAFR) will all be screened.

  4. Screening plasma levels of triglycerides.

    Time frame: The outcomes of this testing will be assessed for up to roughly 6 months through study completion.

    PRP levels of triglycerides will also be screened.

Sponsors and collaborators

Lead sponsor

University of Limerick

Other

Registry information

Official study title

Antithrombotic Activities of a Novel Yogurt Drink: a Dietary Intervention Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 8, 2022
Registry last updated
Nov 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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