Cardiovascular DiseasesNCT05290883
Antithrombotic Activities of a Novel Yoghurt Drink: a Postprandial Study
A study testing Novel yoghurt drink containing Polar Lipids in people with Cardiovascular Diseases, run by University of Limerick at 1 site in Ireland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Novel yoghurt drink containing Polar Lipids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIreland
- Study dates
- 14 May 2021to 25 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Healthy subjects need to have their dietary and dairy intake within the range [1-2 serves per week]
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Novel yoghurt drink containing Polar Lipids
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel yoghurt drink containing Polar LipidsDietary supplement
Postprandial decreased platelet activation/aggregation in subjects, after the yoghurt drink consumption
| Study group | Role | What they receive |
|---|---|---|
| Group A: Yoghurt drink (polar lipid) intervention | Experimental | Not described Receives: Dietary Supplement: Novel yoghurt drink containing Polar Lipids |
What is being measured
The primary outcome is the main question the study is designed to answer.
An investigation of anti-platelet or antithrombotic effect of novel yoghurt drink by platelet aggregometry
An investigation of anti-platelet or antithrombotic effect of novel yoghurt drink by platelet aggregometry will be carried out. The postprandial effect of novel yoghurt drink will be studied by using a platelet aggregation method as per literature. The antithrombotic effect of yoghurt drink lipids will be studied, using PAF and TRAP as platelet aggregation mediators. The investigation will be based on the study-specific platelet aggregometry analysis. Subjects will come to the lab after overnight fasting and they will be provided yoghurt drink (200mL); the activation of their platelets will be monitored over a period of 4 hours (0 to 4 hours study with 1 hour check points).
Measured: 0 mins (preprandially) to 240 mins (postprandially)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start14 May 2021
- Primary completion18 Jul 2021
- Study completion25 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ioannis Zabetakis, University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290883
- Sponsor's protocol ID
- S&E REC No. 2022_01_01_S&E
- Status last verified
- Nov 2022
- First submitted
- 4 Mar 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30619728
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antithrombotic Activities of a Novel Yoghurt Drink: a Postprandial Study
- ClinicalTrials.gov ID
- NCT05290883
- Acronym / sponsor ID
- S&E REC No. 2022_01_01_S&E
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Study start
- 14 May 2021 (actual)
- Primary completion
- 18 Jul 2021 (actual)
- Study completion
- 25 Aug 2021 (actual)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A: Yoghurt drink (polar lipid) intervention | Experimental | Dietary Supplement: Novel yoghurt drink containing Polar Lipids |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- • Healthy subjects need to have their dietary and dairy intake within the range [1-2 serves per week]
Key exclusion criteria (3 listed)
- Subjects will be excluded from the study if they are
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel yoghurt drink containing Polar LipidsPostprandial decreased platelet activation/aggregation in subjects, after the yoghurt drink consumption | Dietary supplement | Group A: Yoghurt drink (polar lipid) intervention |
Primary outcome
An investigation of anti-platelet or antithrombotic effect of novel yoghurt drink by platelet aggregometry
Time frame: 0 mins (preprandially) to 240 mins (postprandially)
An investigation of anti-platelet or antithrombotic effect of novel yoghurt drink by platelet aggregometry will be carried out. The postprandial effect of novel yoghurt drink will be studied by using a platelet aggregation method as per literature. The antithrombotic effect of yoghurt drink lipids will be studied, using PAF and TRAP as platelet aggregation mediators. The investigation will be based on the study-specific platelet aggregometry analysis. Subjects will come to the lab after overnight fasting and they will be provided yoghurt drink (200mL); the activation of their platelets will be monitored over a period of 4 hours (0 to 4 hours study with 1 hour check points).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Background: PubMed 30619728Tsoupras 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel yoghurt drink containing Polar Lipids in people with Cardiovascular Diseases, run by University of Limerick at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
An investigation of anti-platelet or antithrombotic effect of novel yoghurt drink by platelet aggregometry (time frame: 0 mins (preprandially) to 240 mins (postprandially)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05290883, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.