Antithrombotic Activities of a Novel Yogurt Drink
Antithrombotic Activities of a Novel Yogurt Drink: a Dietary Intervention Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Limerick, Ireland
- University of Limerick
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / 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. |
Novel ovine yogurt drink containing polar lipids
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|
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. |
Placebo drink (skimmed milk)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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.
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Participants' platelet activity will be assessed for up to roughly 6 months through study completion
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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.
|
The outcomes of this testing will be assessed for up to roughly 6 months through study completion.
|
|
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.
|
The outcomes of this testing will be assessed for up to roughly 6 months through study completion.
|
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Screening plasma levels of triglycerides.
Time Frame: The outcomes of this testing will be assessed for up to roughly 6 months through study completion.
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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.
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022_01_01_S&E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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