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Antithrombotic Activities of a Novel Yogurt Drink

Sponsor
University of Limerick (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05318911
Collaborator
(none)
20
Enrollment
2
Arms
3.3
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Novel yogurt drink
  • Other: Placebo Drink
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Antithrombotic Activities of a Novel Yogurt Drink: a Dietary Intervention Study
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Jul 15, 2022
Anticipated Study Completion Date :
Aug 8, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Dietary Supplement: Novel yogurt drink
Novel ovine yogurt drink containing polar lipids
Placebo Comparator: 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.

Other: Placebo Drink
Placebo drink (skimmed milk)

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Limerick

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ioannis Zabetakis, Head of Department of Biological Sciences, University of Limerick
ClinicalTrials.gov Identifier:
NCT05318911
Other Study ID Numbers:
  • 2022_01_01_S&E
First Posted:
Apr 8, 2022
Last Update Posted:
Apr 8, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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 Apr 8, 2022