Cardio-protectionVCFNCT07061431
In Vitro and in Vivo Evaluation of the Anti-Inflammatory and Antithrombotic Synergy of Vitamin C and Bioflavonoids in Healthy Subjects
A study testing High Dose of Vitamin C with ir without 50 mg of flavonoids in people with Cardio-protection, run by Democritus University of Thrace at 1 site in Greece.
Trial summary
This study aimed to evaluate the antioxidant potential, and especially the anti-inflammatory and antiplatelet biological efficacy and synergy of a high dose (1 g) vitamin C - low dose (50 mg) bioflavonoid (VCF) based supplement using both in vitro approaches and an and in vivo clinical trial in human platelets from… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardio-protection
- What is being tested?
- High Dose of Vitamin C with ir without 50 mg of flavonoids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- 1 Oct 2024to 31 May 2025
- 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
- Subjects should:
- not have a pathological condition related to platelet and leukocyte activity
- not have a chronic pathological condition
- have a normal BMI
- not take medications that have anti-inflammatory and/or antithrombotic effects
Who cannot join
- If Subjects
- have a pathological condition related to platelet and leukocyte activity
- have a chronic pathological condition
- not have a normal BMI
- take medications that have anti-inflammatory and/or antithrombotic effects
Trial locations and contacts
1 site in 1 country.
Greece1 site
School of Chemistry, Faculty of Sciences, Democritus University of Thrace
Kavala, Kavala, 65404
About this study
Official title: In Vitro and in Vivo Evaluation of the Anti-Inflammatory and Antithrombotic Efficacy of Natural Bioactives in Human Platelets
This study aimed to evaluate the antioxidant potential, and especially the anti-inflammatory and antiplatelet biological efficacy and synergy of a high dose (1 g) vitamin C - low dose (50 mg) bioflavonoid (VCF) based supplement using both in vitro approaches and an and in vivo clinical trial in human platelets from healthy subjects administered orally for 1 month the VCF supplement (VCF Group) versus the administration of a 1 g vitamin C supplement (VC Group).
Read the detailed description
For the In vivo clinical study, blood samples were collected from all participants at baseline (day 0), prior to supplementation (t = 0), and again after 28 days of daily supplementation of VC or VCF. Platelet aggregation was evaluated using three agonists: platelet activating factor (PAF), ADP, and thrombin. Immediately after collection, blood samples collected in citrate containing monovette tubes were centrifuged at 194 × g for 18 minutes at 24 °C to isolate platelet-rich plasma (PRP). The remaining blood was subsequently centrifuged at 1465 × g for 20 minutes at 24 °C to obtain platelet-poor plasma (PPP). PRP and PPP were separated into distinct tubes for further analysis. For aggregometry assays, 250 μL of PRP containing a magnetic stir bar and 500 μL of PPP without stir bar were transferred to each aggregometer cuvette and placed at the appropriate positions at the aggregometer. Platelet aggregation was quantified by determining the mean EC₅₀ values, representing the concentration of each agonist required to induce 50% platelet aggregation. These values were normalized per gram of total content , vitamin C , and flavonoid content as regarding vitamin C and flavonoid supplement. The change in EC₅₀ values after 28 days of supplementation provided an indication of the supplement's modulatory effect on platelet aggregation
- Conditions
- Cardio-protection
- Being tested
- High Dose of Vitamin C with ir without 50 mg of flavonoids
- Keywords
- Anti-platelet, Anti-inflammatory, PAF, Thrombin, ADP, cardio-protective, platelet aggregation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Dose of Vitamin C with ir without 50 mg of flavonoidsDietary supplement
The anti-inflammatory and anti-platelet efficacy and synergy of a supplement containing high dose (1 g) of vitamin C and a low dose (50 mg) citrus and rose bioflavonoids (VCF), was assessed in platelets of blood samples collected from healthy subjects, prior the oral administration (t=0 days) and just after this administration for 1 month (VCF Group), VERSUS the findings from the same procedure contacted for a supplement containing only high dose (1 g) of vitamin C (VC Group)
| Study group | Role | What they receive |
|---|---|---|
| VCF Group | Active comparator | Group of healthy subjects that recieved orally a high dose (1 g) vitamin C supplement containing also a low dose (50 mg) citrus and rose bioflavonoids (VCF), for 28 days Receives: Dietary Supplement: High Dose of Vitamin C with ir without 50 mg of flavonoids |
| VC | Active comparator | Group of healthy subjects that recieved orally a high dose (1 g) vitamin C supplement, for 28 days Receives: Dietary Supplement: High Dose of Vitamin C with ir without 50 mg of flavonoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-platelet cardio-protective efficacy
The increase of the EC50 values of PAF/ADP/Thrombin induced platelet aggregation in the VCF Group versus the VC Group
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start1 Oct 2024
- Primary completion31 Mar 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardio-protectionStudies 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandros Tsoupras, Democritus University of Thrace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061431
- Sponsor's protocol ID
- ΔΠΘ/ΕHΔΕ/7690/70, 27-9-2024
- Acronym
- VCF
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro and in Vivo Evaluation of the Anti-Inflammatory and Antithrombotic Efficacy of Natural Bioactives in Human Platelets
- ClinicalTrials.gov ID
- NCT07061431
- Acronym / sponsor ID
- VCF / ΔΠΘ/ΕHΔΕ/7690/70, 27-9-2024
- Conditions
- Cardio-protection
- Keywords
- Anti-platelet, Anti-inflammatory, PAF, Thrombin, ADP, cardio-protective, platelet aggregation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 11 Jul 2025 (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.
This study aimed to evaluate the antioxidant potential, and especially the anti-inflammatory and antiplatelet biological efficacy and synergy of a high dose (1 g) vitamin C - low dose (50 mg) bioflavonoid (VCF) based supplement using both in vitro approaches and an and in vivo clinical trial in human platelets from healthy subjects administered orally for 1 month the VCF supplement (VCF Group) versus the administration of a 1 g vitamin C supplement (VC Group).
Detailed description
For the In vivo clinical study, blood samples were collected from all participants at baseline (day 0), prior to supplementation (t = 0), and again after 28 days of daily supplementation of VC or VCF. Platelet aggregation was evaluated using three agonists: platelet activating factor (PAF), ADP, and thrombin. Immediately after collection, blood samples collected in citrate containing monovette tubes were centrifuged at 194 × g for 18 minutes at 24 °C to isolate platelet-rich plasma (PRP). The remaining blood was subsequently centrifuged at 1465 × g for 20 minutes at 24 °C to obtain platelet-poor plasma (PPP). PRP and PPP were separated into distinct tubes for further analysis. For aggregometry assays, 250 μL of PRP containing a magnetic stir bar and 500 μL of PPP without stir bar were transferred to each aggregometer cuvette and placed at the appropriate positions at the aggregometer. Platelet aggregation was quantified by determining the mean EC₅₀ values, representing the concentration of each agonist required to induce 50% platelet aggregation. These values were normalized per gram of total content , vitamin C , and flavonoid content as regarding vitamin C and flavonoid supplement. The change in EC₅₀ values after 28 days of supplementation provided an indication of the supplement's modulatory effect on platelet aggregation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VCF Group | Active comparator | Dietary Supplement: High Dose of Vitamin C with ir without 50 mg of flavonoidsGroup of healthy subjects that recieved orally a high dose (1 g) vitamin C supplement containing also a low dose (50 mg) citrus and rose bioflavonoids (VCF), for 28 days |
| VC | Active comparator | Dietary Supplement: High Dose of Vitamin C with ir without 50 mg of flavonoidsGroup of healthy subjects that recieved orally a high dose (1 g) vitamin C supplement, for 28 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- not have a pathological condition related to platelet and leukocyte activity
- not have a chronic pathological condition
- have a normal BMI
- not take medications that have anti-inflammatory and/or antithrombotic effects
Key exclusion criteria (5 listed)
- If Subjects
- have a pathological condition related to platelet and leukocyte activity
- have a chronic pathological condition
- not have a normal BMI
- take medications that have anti-inflammatory and/or antithrombotic effects
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 |
|---|---|---|
| High Dose of Vitamin C with ir without 50 mg of flavonoidsThe anti-inflammatory and anti-platelet efficacy and synergy of a supplement containing high dose (1 g) of vitamin C and a low dose (50 mg) citrus and rose bioflavonoids (VCF), was assessed in platelets of blood samples collected from healthy subjects, prior the oral administration (t=0 days) and just after this administration for 1 month (VCF Group), VERSUS the findings from the same procedure contacted for a supplement containing only high dose (1 g) of vitamin C (VC Group) | Dietary supplement | VC, VCF Group |
Primary outcome
Anti-platelet cardio-protective efficacy
Time frame: 1 month
The increase of the EC50 values of PAF/ADP/Thrombin induced platelet aggregation in the VCF Group versus the VC Group
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 11 Jul 2025.
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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 High Dose of Vitamin C with ir without 50 mg of flavonoids in people with Cardio-protection, run by Democritus University of Thrace 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 5 inclusion and 5 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 11 Jul 2025. 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. 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?
Anti-platelet cardio-protective efficacy (time frame: 1 month). 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 11 Jul 2025.