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Antithrombotic Activities of a Novel Yoghurt Drink: a Postprandial Study

U

University of Limerick

Status

Completed

Conditions

Cardiovascular Diseases

Treatments

Dietary Supplement: Novel yoghurt drink containing Polar Lipids

Study type

Interventional

Funder types

Other

Identifiers

NCT05290883
S&E REC No. 2022_01_01_S&E

Details and patient eligibility

About

The project aims to investigate the antithrombotic activity of the novel yoghurt drink enriched with polar lipids derived from ovine milk. The health claims the formulated novel or functional food on EFSA guidelines "The scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health" and in a particular paragraph 5.4, "Claims on reduced platelet aggregation" "Platelet hyperactivity and hypercoagulability states are more commonly observed in subjects with cardiovascular (CV) risk factors. Healthy subjects or participants at very low risk of CV disease normally have non-activated circulating platelets. Reducing platelet aggregation in subjects with platelet activation during sustained exposure to the food/constituent (e.g., four weeks) would be a beneficial physiological effect".

Within this investigation, the postprandial effects of this novel yoghurt drink against platelet aggregation are going to be studied ex vivo in blood from healthy human subjects as described in previously established procedures.

Enrollment

5 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • • Healthy subjects need to have their dietary and dairy intake within the range [1-2 serves per week]

Exclusion criteria

  • Subjects will be excluded from the study if they are

    • Under medication and intake of dietary supplements
    • Treatment for blood clotting disorders or dyslipidaemia

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

5 participants in 1 patient group

Group A: Yoghurt drink (polar lipid) intervention
Experimental group
Treatment:
Dietary Supplement: Novel yoghurt drink containing Polar Lipids

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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