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

NCT07061431 | Completed

• 1 other identifier: ΔΠΘ/ΕHΔΕ/7690/70, 27-9-2024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardio-protection

Keywords

Anti-platelet; Anti-inflammatory; PAF; Thrombin; ADP; cardio-protective; platelet aggregation

Outcome Measures

Primary Outcomes (1)

• 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

  1 month

Study Arms (2)

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

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

Dietary Supplement: High Dose of Vitamin C with ir without 50 mg of flavonoids

Interventions

High Dose of Vitamin C with ir without 50 mg of flavonoids 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; VCF Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Democritus University of Thrace: lead

Study Sites (1)

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

Kavala, Kavala, 65404, Greece

Location

MeSH Terms

Interventions

Ascorbic Acid; Flavonoids

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: October 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: May 31, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

GR (1)