Antithrombotic Activities of a Novel Yogurt Drink

University of Limerick

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Dietary Supplement: Novel yogurt drink; Other: Placebo Drink

Study type: Interventional

Funder types: Other

Identifiers

NCT05318911

2022_01_01_S&E

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

20 participants in 2 patient groups, including a placebo group

Supplement Group

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Novel yogurt drink

Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo Drink