NCT05318911

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 4, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
23 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

November 7, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

March 4, 2022

Last Update Submit

November 2, 2022

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (4)

  • Platelet aggregation of PRP samples in the presence of PAF

    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.

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

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

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

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

  • Screening plasma levels of inflammatory markers.

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

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

  • Screening plasma levels of triglycerides.

    PRP levels of triglycerides will also be screened.

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

Study Arms (2)

Supplement Group

ACTIVE COMPARATOR

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Novel yogurt drinkDIETARY_SUPPLEMENT

Novel ovine yogurt drink containing polar lipids

Supplement Group
Placebo DrinkOTHER

Placebo drink (skimmed milk)

Placebo Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Limerick

Limerick, Ireland

Location

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

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Biological Sciences

Study Record Dates

First Submitted

March 4, 2022

First Posted

April 8, 2022

Study Start

May 1, 2022

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

November 7, 2022

Record last verified: 2022-11

Locations

IE(1)