Platelet Aggregation and InflammationNAPENCT04436263
Cardioprotective Properties of Natural Anti-Platelet Activating Factor Extract From Winery By-products in Healthy Women
A study testing Supplement in people with Platelet Aggregation and Inflammation, run by Harokopio University at 1 site in Greece.
Trial summary
The purpose of this study is to investigate the anti-platelet and anti-inflammatory properties of a winery by-products extract as well as to detect extract compounds and their metabolites in biological fluids. The study is a randomized, double-blind, crossover, placebo controlled postprandial study in healthy women. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Platelet Aggregation and Inflammation
- What is being tested?
- Supplement
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteGreece
- Study dates
- 20 Jan 2020to 20 Jun 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 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Females
- BMI: 22-32 kg/m2
Who cannot join
- Systematic medication
- Chronic disease conditions
- Specific dietary conditions (vegeterian, vegan...)
- Eating disorders
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Department of Nutrition-Dietetics, Harokopio University
Athens, 17671
Elizabeth Fragopoulou, PhD, 2109549249 ext. 0030, efragop@hua.gr
Elizabeth Fragopoulou, PhD
About this study
Official title: Investigation of in Vivo Anti-inflammatory and Anti-platelet Mechanisms of Natural Extract by Modulating PAF Metabolism and Actions
The purpose of this study is to investigate the anti-platelet and anti-inflammatory properties of a winery by-products extract as well as to detect extract compounds and their metabolites in biological fluids. The study is a randomized, double-blind, crossover, placebo controlled postprandial study in healthy women.
Read the detailed description
The well-known cardioprotective and metabolic effects of wine consumption are mainly attributed to its micro-constituents. Grape pomace (GP) is a by-product of the winemaking process and consists mainly of skins and seeds. Winery by-products are a cheap and rich source of similar-to wine micro-constituents, which can be used either to enrich other foods or to be included in food supplements targeting the prevention or partially the therapy of cardiovascular diseases.In this line, our previous results revealed the potent in vitro anti-platelet effects of a specific ethanol-water extract rich in Platelet-Activating Factor inhibitors from winery by-products.
The purpose of this study is to investigate the in vivo anti-platelet and anti-inflammatory properties of the specific winery by-products extract as well as to detect the extract compounds and their metabolites in biological fluids.
Therefore a randomized double-blind, crossover, placebo controlled postprandial study in healthy women will be implemented. For this purpose, 15 healthy women will participate in the protocol. The two daily trials will take place during specific days based on their menstrual cycle. Three days before each blood collection the volunteers will be instructed to abstain from food and beverages rich in phenolic compounds and their dietary intake will be recorded (three 24h recalls and one food frequency questionnaire). The blood collections will be carried out after 8h fasting. At trial day, the volunteers will bring the first morning urine sample and anthropometric measurements will take place (weight, height, waist/hip circumference, bioelectrical impedance). Then a venous catheter will be placed and after 10 minutes the fasting blood will be collected. Volunteers will proceed to the consumption of a standardized meal (1131 kcal, 19.7% carbohydrates, 11.2% protein, 66.7% fat) along with the capsules (study extract or placebo). The type of the capsules consumed (study extract or placebo) will be randomized and blind during the two intervention days for both volunteers and investigators. Blood will be drown after the meal consumption and for the next 6h (every 30minutes for the first 4h and every 1h for the next 2h). Serum, plasma, platelet-rich plasma, leukocyte-rich plasma and urine samples will be isolated at certain time points during trial days so that the anti-platelet, anti-inflammatory and antioxidant effects of the study extract can be evaluated.
- Conditions
- Platelet Aggregation and Inflammation
- Being tested
- Supplement, Placebo
- Keywords
- winery by-products, natural extract, postprandial study, platelet aggregation, anti-inflammatory, healthy women, Platelet-activating factor
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SupplementBehavioural
A sufficient quantity of the winery by-products will be extracted on an industrial scale and capsules will be produced, each one containing 110mg of phenolic compounds (gallic acid equivalents).Volunteers will consume 6 capsules along with a standardized meal (1131 kcal, 19.7% carbohydrates, 11.2% protein, 66.7% fat) and blood will be drown before the meal consumption and at specific time points for the next 6h
PlaceboBehavioural
A look-alike placebo containing maltodextrin will be prepared.Volunteers will consume 6 capsules along with a standardized meal (1131 kcal, 19.7% carbohydrates, 11.2% protein, 66.7% fat) and blood will be drown before the meal consumption and at specific time points for the next 6h
| Study group | Role | What they receive |
|---|---|---|
| Supplement | Experimental | Ethanol-water extract of winery by-products Receives: Behavioral: Supplement |
| Placebo | Placebo comparator | Maltodextrin-based placebo Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on platelet aggregation
% Change of EC50 value of platelet aggregation against PAF
Measured: Change between timepoints (before meal consumption, 30min, 90min, 150min, 210min, 300min) of the 6hour trial and between the two different interventions
Effect on platelet aggregation
% Change of EC50 value of platelet aggregation against ADP
Measured: Change between timepoints (before meal consumption, 30min, 90min, 150min, 210min, 300min) of the 6hour trial and between the two different interventions
Effect on platelet aggregation
% Change of EC50 value of platelet aggregation against Collagen
Measured: Change between timepoints (before meal consumption, 30min, 90min, 150min, 210min, 300min) of the 6hour trial and between the two different interventions
Effect on inflammatory markers
Change in PAF biosynthetic enzymes activity (lyso-PAF AT)
Measured: Change between timepoints (before meal consumption, 60min, 120min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
Effect on inflammatory markers
Change in PAF biosynthetic enzymes activity (PAF-CPT)
Measured: Change between timepoints (before meal consumption, 60min, 120min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
Effect on inflammatory markers
Change in PAF levels Change in PAF degradation enzyme activity (Lp-PLA2) Change in PAF levels IL6
Measured: Change between timepoints (before meal consumption, 60min, 120min, 180min, 240min, 360min) of the 6hour trial and between the two different interventions
Effect on inflammatory markers
Change in PAF degradation enzyme activity (Lp-PLA2)
Measured: Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
Effect on inflammatory markers
IL-6
Measured: Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
Secondary outcomes (8)
Effect on classical biochemical markers
Total serum cholesterol
Measured: Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
Effect on classical biochemical markers
LDL-cholesterol
Measured: Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
Effect on classical biochemical markers
HDL-cholesterol
Measured: Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
Effect on classical biochemical markers
TAG
Measured: Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
Effect on classical biochemical markers
uric acid
Measured: Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
Effect on classical biochemical markers
Glucose
Measured: Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
Effect on classical biochemical markers
Insulin
Measured: Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
Detection and estimation of extract compounds metabolites
Measured: Change between timepoints (before meal consumption, 60min, 120min, 240min, 360min) of the 6hour trial and between the two different interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start20 Jan 2020
- Primary completion20 Jun 2021 (estimated)
- Study completion20 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet Aggregation and InflammationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Fragopoulou, Harokopio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436263
- Sponsor's protocol ID
- HarokopioU_anti-PAF extract
- Acronym
- NAPE
- Status last verified
- Jun 2020
- First submitted
- 15 Jun 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of in Vivo Anti-inflammatory and Anti-platelet Mechanisms of Natural Extract by Modulating PAF Metabolism and Actions
- ClinicalTrials.gov ID
- NCT04436263
- Acronym / sponsor ID
- NAPE / HarokopioU_anti-PAF extract
- Conditions
- Platelet Aggregation and Inflammation
- Keywords
- winery by-products, natural extract, postprandial study, platelet aggregation, anti-inflammatory, healthy women, Platelet-activating factor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 20 Jun 2021 (estimated)
- Study completion
- 20 Jun 2021 (estimated)
- First posted
- 18 Jun 2020 (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 purpose of this study is to investigate the anti-platelet and anti-inflammatory properties of a winery by-products extract as well as to detect extract compounds and their metabolites in biological fluids. The study is a randomized, double-blind, crossover, placebo controlled postprandial study in healthy women.
Detailed description
The well-known cardioprotective and metabolic effects of wine consumption are mainly attributed to its micro-constituents. Grape pomace (GP) is a by-product of the winemaking process and consists mainly of skins and seeds. Winery by-products are a cheap and rich source of similar-to wine micro-constituents, which can be used either to enrich other foods or to be included in food supplements targeting the prevention or partially the therapy of cardiovascular diseases.In this line, our previous results revealed the potent in vitro anti-platelet effects of a specific ethanol-water extract rich in Platelet-Activating Factor inhibitors from winery by-products.
The purpose of this study is to investigate the in vivo anti-platelet and anti-inflammatory properties of the specific winery by-products extract as well as to detect the extract compounds and their metabolites in biological fluids.
Therefore a randomized double-blind, crossover, placebo controlled postprandial study in healthy women will be implemented. For this purpose, 15 healthy women will participate in the protocol. The two daily trials will take place during specific days based on their menstrual cycle. Three days before each blood collection the volunteers will be instructed to abstain from food and beverages rich in phenolic compounds and their dietary intake will be recorded (three 24h recalls and one food frequency questionnaire). The blood collections will be carried out after 8h fasting. At trial day, the volunteers will bring the first morning urine sample and anthropometric measurements will take place (weight, height, waist/hip circumference, bioelectrical impedance). Then a venous catheter will be placed and after 10 minutes the fasting blood will be collected. Volunteers will proceed to the consumption of a standardized meal (1131 kcal, 19.7% carbohydrates, 11.2% protein, 66.7% fat) along with the capsules (study extract or placebo). The type of the capsules consumed (study extract or placebo) will be randomized and blind during the two intervention days for both volunteers and investigators. Blood will be drown after the meal consumption and for the next 6h (every 30minutes for the first 4h and every 1h for the next 2h). Serum, plasma, platelet-rich plasma, leukocyte-rich plasma and urine samples will be isolated at certain time points during trial days so that the anti-platelet, anti-inflammatory and antioxidant effects of the study extract can be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplement | Experimental | Behavioral: SupplementEthanol-water extract of winery by-products |
| Placebo | Placebo comparator | Behavioral: PlaceboMaltodextrin-based placebo |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy
- Females
- BMI: 22-32 kg/m2
Key exclusion criteria (4 listed)
- Systematic medication
- Chronic disease conditions
- Specific dietary conditions (vegeterian, vegan...)
- Eating disorders
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 |
|---|---|---|
| SupplementA sufficient quantity of the winery by-products will be extracted on an industrial scale and capsules will be produced, each one containing 110mg of phenolic compounds (gallic acid equivalents).Volunteers will consume 6 capsules along with a standardized meal (1131 kcal, 19.7% carbohydrates, 11.2% protein, 66.7% fat) and blood will be drown before the meal consumption and at specific time points for the next 6h | Behavioural | Supplement |
| PlaceboA look-alike placebo containing maltodextrin will be prepared.Volunteers will consume 6 capsules along with a standardized meal (1131 kcal, 19.7% carbohydrates, 11.2% protein, 66.7% fat) and blood will be drown before the meal consumption and at specific time points for the next 6h | Behavioural | Placebo |
Primary outcome
Effect on platelet aggregation
Time frame: Change between timepoints (before meal consumption, 30min, 90min, 150min, 210min, 300min) of the 6hour trial and between the two different interventions
% Change of EC50 value of platelet aggregation against PAF
Effect on platelet aggregation
Time frame: Change between timepoints (before meal consumption, 30min, 90min, 150min, 210min, 300min) of the 6hour trial and between the two different interventions
% Change of EC50 value of platelet aggregation against ADP
Effect on platelet aggregation
Time frame: Change between timepoints (before meal consumption, 30min, 90min, 150min, 210min, 300min) of the 6hour trial and between the two different interventions
% Change of EC50 value of platelet aggregation against Collagen
Effect on inflammatory markers
Time frame: Change between timepoints (before meal consumption, 60min, 120min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
Change in PAF biosynthetic enzymes activity (lyso-PAF AT)
Effect on inflammatory markers
Time frame: Change between timepoints (before meal consumption, 60min, 120min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
Change in PAF biosynthetic enzymes activity (PAF-CPT)
Effect on inflammatory markers
Time frame: Change between timepoints (before meal consumption, 60min, 120min, 180min, 240min, 360min) of the 6hour trial and between the two different interventions
Change in PAF levels Change in PAF degradation enzyme activity (Lp-PLA2) Change in PAF levels IL6
Effect on inflammatory markers
Time frame: Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
Change in PAF degradation enzyme activity (Lp-PLA2)
Effect on inflammatory markers
Time frame: Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
IL-6
8 secondary outcomes
Effect on classical biochemical markers
Time frame: Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
Effect on classical biochemical markers
Time frame: Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
Effect on classical biochemical markers
Time frame: Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
Effect on classical biochemical markers
Time frame: Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
Effect on classical biochemical markers
Time frame: Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
Effect on classical biochemical markers
Time frame: Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
Effect on classical biochemical markers
Time frame: Change between timepoints (before meal consumption, 0min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 300min, 360min) of the 6hour trial and between the two different interventions
Detection and estimation of extract compounds metabolites
Time frame: Change between timepoints (before meal consumption, 60min, 120min, 240min, 360min) of the 6hour trial and between the two different interventions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Platelet Aggregation and Inflammation
Active, not recruiting
The Effects of Dietary Erythritol on Platelet Reactivity and Vascular Inflammation
Platelet Aggregation, Spontaneous, Vascular Thrombosis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplement in people with Platelet Aggregation and Inflammation, 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 3 inclusion and 4 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 18 Jun 2020. 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 Elizabeth Fragopoulou, PhD (2109549249 ext. 0030, efragop@hua.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on platelet aggregation (time frame: Change between timepoints (before meal consumption, 30min, 90min, 150min, 210min, 300min) of the 6hour trial and between the two different interventions). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2020.