In Vitro and in Vivo Evaluation of the Anti-Inflammatory and Antithrombotic Synergy of Vitamin C and Bioflavonoids in Healthy Subjects

NCT ID: NCT07061431

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-05-31

Brief 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 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

Conditions

Cardio-protection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

VCF Group

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

Group Type: ACTIVE_COMPARATOR

High Dose of Vitamin C with ir without 50 mg of flavonoids

Intervention Type: DIETARY_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)

VC

Group of healthy subjects that recieved orally a high dose (1 g) vitamin C supplement, for 28 days

Group Type: ACTIVE_COMPARATOR

High Dose of Vitamin C with ir without 50 mg of flavonoids

Intervention Type: DIETARY_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)

Interventions

High Dose of Vitamin C with ir without 50 mg of flavonoids

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)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Democritus University of Thrace

OTHER

Sponsor Role: lead

Responsible Party

Alexandros Tsoupras

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School of Chemistry, Faculty of Sciences, Democritus University of Thrace

Kavala, Kavala, Greece

Countries

Greece

Other Identifiers

ΔΠΘ/ΕHΔΕ/7690/70, 27-9-2024

Identifier Type: -

Identifier Source: org_study_id