Cardiovascular DiseasesNCT02259205
Cardio Protective Properties of a Yogurt Enriched With Bioactive Lipids of Olive Oil Products
A study testing Enriched Yogurt and Plain Yogurt in people with Cardiovascular Diseases, run by Harokopio University at 1 site in Greece.
Trial summary
This study evaluates the effectiveness of a yogurt enriched with bioactive lipids extracted from olive mill waste in platelet aggregation and other inflammatory and oxidative stress markers. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Enriched Yogurt and Plain Yogurt
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- Sep 2014to Oct 2015
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All individuals, aged 40-60 years, without any of the exclusion criteria
Who cannot join
- Any anti-inflammatory medication
- Hyper-lipidemic medications
- Use of antibiotics within two months from study entry
- Pregnancy or childbirth in the previous year
- Intake of any nutritional supplement
- Any serious dental, respiratory, liver, kidney, gastrointestinal disease
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Harokopio University, Department of Nutrition and Dietetics
Athens, Attica, 17671
George Milias, PhD, +302109549100 ext. 181, gmilias@yahoo.com
Costas Anastasiou, PhD, +302109549100 ext. 181, acostas@hua.gr
About this study
This study evaluates the effectiveness of a yogurt enriched with bioactive lipids extracted from olive mill waste in platelet aggregation and other inflammatory and oxidative stress markers. The study will include three groups: the intervention group will receive the enriched yogurt while the other two groups will serve as controls (plain yogurt and no yogurt consumption).
Read the detailed description
Cardiovascular diseases are the leading cause of mortality worldwide. Data from the investigators research group indicate that platelet activating factor (PAF) is one of the most important inflammatory factors and the main mediator of thrombosis during the formation of atherosclerotic plaque. Thus, dietary interventions aimed at inhibition of PAF is of particular importance in public health level. The aim of the study is to examine the efficacy of administering in humans bioactive lipids extracted from olive mill waste (with proven in vitro anti-thrombotic activity and in vivo anti-atherosclerotic properties in rabbits fed an atherogenic diet) to inhibit the activity of PAF and other inflammatory mediators.
Bioactive lipids are isolated by standardized methodology of oil manufacture byproducts. Preliminary studies have been done in animals to establish the safety of administration of these compounds and to clarify the effective dosages of administration for inhibiting formation of atherosclerotic plaques. The effectiveness of these compounds in humans will be examined in a randomized, double-blind clinical trial in subjects aged 40-60 years, lasting eight weeks. Supplementation with the bioactive lipids will be in the form of an enriched yogurt provided daily. The study includes three groups: treatment group, where enriched yogurt will be provided, plain yogurt treatment group and no consumption of yogurt group . Parameters that will be assessed are the inhibition of platelet aggregation (with three different stimuli, including PAF), lipid profile, inflammatory markers such as CRP, IL-6, TNFa, and oxidative stress markers.
- Conditions
- Cardiovascular Diseases
- Being tested
- Enriched Yogurt, Plain Yogurt
- Keywords
- platelet activating factor, inflammatory markers, yogurt, olive oil, platelet aggregation, oxidative stress, endothelial damage, bioactive 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.
Enriched YogurtOther
150 g yogurt enriched with bioactive lipids extract from olive oil mill will be provided daily for 8 weeks
Plain YogurtOther
150 g plain yogurt will be provided daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Enriched Yogurt | Experimental | 150 g yogurt enriched with approximately 0.5 g bioactive lipids extract from olive oil mill provided daily for 8 weeks Receives: Other: Enriched Yogurt |
| Plain Yogurt | Placebo comparator | 150 g not enriched yogurt provided daily for 8 weeks Receives: Other: Plain Yogurt |
| Control | No intervention | No yogurt consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Platelet aggregation
The ability of platelets to aggregate will be measured in platelet rich plasma (PRP) of volunteers using PAF, thrombin and ADP as aggregating factor.
Measured: 0 (baseline), end of 4th week and 8th week
Secondary outcomes (7)
Changes in Blood lipid profile
Blood levels of cholesterol, LDL-cholesterol, HDL-cholesterol and triacylglycerols will be measured.
Measured: 0 (baseline), end of 4th week and 8th week
Changes in Glucose and Insulin
Blood levels of glucose and insulin
Measured: 0 (baseline), end of 4th week and 8th week
Changes in Gastro-intestinal symptoms
Gastro-intestinal symptoms and possible side effects from yogurt consumption will be assessed through validated questionnaires.
Measured: 0 (baseline), end of 4th week and 8th week
Change in Dietary intake
Dietary intake will be assessed through two dietary recalls and a food frequency questionnaire at each time point.
Measured: 0 (baseline), end of 8th week
Changes in Oxidative stress
Ex vivo serum oxidation as a marker for lipid oxidation and protein carbonyls as a marker for protein oxidation will be measured.
Measured: 0 (baseline), end of 4th week and 8th week
Changes in Gut microbiota populations
the populations of lactobacilli, bifidobacteria and Clostridium histolyticum group will be estimated by real-time PCR using genus specific primers. Furthermore, the metabolic products of the gut microorganisms will be evaluated by measuring the short chain fatty acids profile in fecal samples.
Measured: 0 (baseline), end of 8th week
Changes in Inflammation-related markers
C-reactive protein (CRP), IL-6, TNFa, IL-10 levels in fasting blood samples.
Measured: 0 (baseline), end of 4th week and 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionJul 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens, Competitiveness and Entrepreneurship (OPCE II), NRSF 2007-13
- Responsible party
- Principal investigator, Smaragdi Antonopoulou, Harokopio University
- Investigators
- Smaragdi Antonopoulou, PhD, Principal investigator, Harokopio University, Department of Nutrition and DieteticsElizabeth Frafopoulou, PhD, Study chair, Harokopio University, Department of Nutrition and DieteticsTzortzis Nomikos, PhD, Study chair, Harokopio University, Department of Nutrition and Dietetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259205
- Sponsor's protocol ID
- 11SYN-2-652
- Other IDs
- HUA
- Status last verified
- Apr 2015
- First submitted
- 24 Sep 2014
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Antonopoulou S, Mitsou EK, Kyriacou A, Fragopoulou E, Detopoulou M. Does Yogurt Enriched with Platelet-Activating Factor Inhibitors from Olive Oil By-Products Affect Gut Microbiota and Faecal Metabolites in Healthy Overweight Subjects? (A randomized, parallel, three arm trial.). Front Biosci (Landmark Ed). 2024 Apr 23;29(4):159. doi: 10.31083/j.fbl2904159.
PubMed 38682205Detopoulou M, Ntzouvani A, Petsini F, Gavriil L, Fragopoulou E, Antonopoulou S. Consumption of Enriched Yogurt with PAF Inhibitors from Olive Pomace Affects the Major Enzymes of PAF Metabolism: A Randomized, Double Blind, Three Arm Trial. Biomolecules. 2021 May 28;11(6):801. doi: 10.3390/biom11060801.
PubMed 34071485
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardio Protective Properties of a Yogurt Enriched With Bioactive Lipids of Olive Oil Products
- ClinicalTrials.gov ID
- NCT02259205
- Acronym / sponsor ID
- 11SYN-2-652
- Conditions
- Cardiovascular Diseases
- Keywords
- platelet activating factor, inflammatory markers, yogurt, olive oil, platelet aggregation, oxidative stress, endothelial damage, bioactive lipids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens, Competitiveness and Entrepreneurship (OPCE II), NRSF 2007-13
- Study start
- Sep 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 8 Oct 2014 (estimated)
- 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.
This study evaluates the effectiveness of a yogurt enriched with bioactive lipids extracted from olive mill waste in platelet aggregation and other inflammatory and oxidative stress markers. The study will include three groups: the intervention group will receive the enriched yogurt while the other two groups will serve as controls (plain yogurt and no yogurt consumption).
Detailed description
Cardiovascular diseases are the leading cause of mortality worldwide. Data from the investigators research group indicate that platelet activating factor (PAF) is one of the most important inflammatory factors and the main mediator of thrombosis during the formation of atherosclerotic plaque. Thus, dietary interventions aimed at inhibition of PAF is of particular importance in public health level. The aim of the study is to examine the efficacy of administering in humans bioactive lipids extracted from olive mill waste (with proven in vitro anti-thrombotic activity and in vivo anti-atherosclerotic properties in rabbits fed an atherogenic diet) to inhibit the activity of PAF and other inflammatory mediators.
Bioactive lipids are isolated by standardized methodology of oil manufacture byproducts. Preliminary studies have been done in animals to establish the safety of administration of these compounds and to clarify the effective dosages of administration for inhibiting formation of atherosclerotic plaques. The effectiveness of these compounds in humans will be examined in a randomized, double-blind clinical trial in subjects aged 40-60 years, lasting eight weeks. Supplementation with the bioactive lipids will be in the form of an enriched yogurt provided daily. The study includes three groups: treatment group, where enriched yogurt will be provided, plain yogurt treatment group and no consumption of yogurt group . Parameters that will be assessed are the inhibition of platelet aggregation (with three different stimuli, including PAF), lipid profile, inflammatory markers such as CRP, IL-6, TNFa, and oxidative stress markers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enriched Yogurt | Experimental | Other: Enriched Yogurt150 g yogurt enriched with approximately 0.5 g bioactive lipids extract from olive oil mill provided daily for 8 weeks |
| Plain Yogurt | Placebo comparator | Other: Plain Yogurt150 g not enriched yogurt provided daily for 8 weeks |
| Control | No intervention | –No yogurt consumption |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All individuals, aged 40-60 years, without any of the exclusion criteria
Key exclusion criteria (6 listed)
- Any anti-inflammatory medication
- Hyper-lipidemic medications
- Use of antibiotics within two months from study entry
- Pregnancy or childbirth in the previous year
- Intake of any nutritional supplement
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 |
|---|---|---|
| Enriched Yogurt150 g yogurt enriched with bioactive lipids extract from olive oil mill will be provided daily for 8 weeks | Other | Enriched Yogurt |
| Plain Yogurt150 g plain yogurt will be provided daily for 8 weeks | Other | Plain Yogurt |
Primary outcome
Changes in Platelet aggregation
Time frame: 0 (baseline), end of 4th week and 8th week
The ability of platelets to aggregate will be measured in platelet rich plasma (PRP) of volunteers using PAF, thrombin and ADP as aggregating factor.
7 secondary outcomes
Changes in Blood lipid profile
Time frame: 0 (baseline), end of 4th week and 8th week
Changes in Glucose and Insulin
Time frame: 0 (baseline), end of 4th week and 8th week
Changes in Gastro-intestinal symptoms
Time frame: 0 (baseline), end of 4th week and 8th week
Change in Dietary intake
Time frame: 0 (baseline), end of 8th week
Changes in Oxidative stress
Time frame: 0 (baseline), end of 4th week and 8th week
Changes in Gut microbiota populations
Time frame: 0 (baseline), end of 8th week
Changes in Inflammation-related markers
Time frame: 0 (baseline), end of 4th week and 8th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
- Derived from this study: PubMed 38682205Antonopoulou S, Mitsou EK, Kyriacou A, Fragopoulou E, Detopoulou M. Does Yogurt Enriched with Platelet-Activating Factor Inhibitors from Olive Oil By-Products Affect Gut Microbiota and Faecal Metabolites in Healthy Overweight Subjects? (A randomized, parallel, three arm trial.). Front Biosci (Landmark Ed). 2024 Apr 23;29(4):159. doi: 10.31083/j.fbl2904159.
- Derived from this study: PubMed 34071485Detopoulou M, Ntzouvani A, Petsini F, Gavriil L, Fragopoulou E, Antonopoulou S. Consumption of Enriched Yogurt with PAF Inhibitors from Olive Pomace Affects the Major Enzymes of PAF Metabolism: A Randomized, Double Blind, Three Arm Trial. Biomolecules. 2021 May 28;11(6):801. doi: 10.3390/biom11060801.
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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.
Smaragdi Antonopoulou, PhD principal investigator
Harokopio University, Department of Nutrition and Dietetics
Elizabeth Frafopoulou, PhD study chair
Harokopio University, Department of Nutrition and Dietetics
Tzortzis Nomikos, PhD study chair
Harokopio University, Department of Nutrition and Dietetics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enriched Yogurt and Plain Yogurt in people with Cardiovascular Diseases, run by Harokopio University at 1 site in Greece.
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 6 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: status not confirmed, as of the sponsor's last update on 8 Apr 2015. 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 Greece. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Smaragdi Antonopoulou, PhD (+302109549100 ext. 230, antonop@hua.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Platelet aggregation (time frame: 0 (baseline), end of 4th week and 8th week). 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 NCT02259205, which also lists 2 linked publications.
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 8 Apr 2015.