Clinical Trials

Multiple clinical trials evaluate the therapeutic potential of flavanone in vascular and metabolic health, investigating conditions such as metabolic syndrome, vascular compliance, and cardiovascular disease risk alongside parameters in healthy volunteers. Spanning Phase 1 and unclassified trial phases, these studies maintain recruitment statuses ranging from active, not recruiting to completed. Sponsored primarily by academic and public research institutes, including University Hospital Clermont-Ferrand and INRAE, these trials assess the vascular protection and immune effects associated with flavanone consumption.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04731987 Active not recruiting
Metabolic Syndrome|Vascular Compliance|Predisposition to Cardiovascular Disease
University Hospital Clermont-Ferrand|UMR 1019 Unité de Nutrition Humaine INRAE Auvergne-Rhône Alpes Center|Department of Beverage Research Chair of analysis and technology of plant-based foods Geisenheim University|European Fruit Juice Association (AIJN)
 2021-02-24 Not Applicable
NCT00983086 Completed
Healthy Volunteers
University Hospital Clermont-Ferrand|Institut National de Recherche pour l''Agriculture l''Alimentation et l''Environnement
 2007-08 Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Flavanone product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Flavanone functions as a potent free radical scavenger and antioxidant agent that directly neutralizes reactive oxygen species and modulates inflammatory signaling pathways. By reducing cellular oxidative stress and inhibiting platelet aggregation, flavanone maintains endothelial integrity and improves vascular compliance, providing a mechanistic basis for its clinical investigation in metabolic syndrome and cardiovascular disease prevention.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.