Study Results
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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COMPLETED
NA
20 participants
INTERVENTIONAL
2022-05-01
2022-09-30
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
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.
Novel yogurt drink
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.
Placebo Drink
Placebo drink (skimmed milk)
Interventions
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Novel yogurt drink
Novel ovine yogurt drink containing polar lipids
Placebo Drink
Placebo drink (skimmed milk)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
60 Years
ALL
Yes
Sponsors
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University of Limerick
OTHER
Responsible Party
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Ioannis Zabetakis
Head of Department of Biological Sciences
Locations
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University of Limerick
Limerick, , Ireland
Countries
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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.
Other Identifiers
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2022_01_01_S&E
Identifier Type: -
Identifier Source: org_study_id
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