Clinical Trials

A clinical trial investigated the physiological and biological effects of Procyanidin B2 supplementation, specifically evaluating how procyanidin B2-enriched cocoa consumption influences mitochondrial biogenesis in athletes. Sponsored by the Universidad Europea de Madrid without a formal phase designation, this completed study focused on cellular and metabolic adaptations within an athletic cohort. Currently, no active or recruiting trials are documented for this natural flavonoid across other clinical settings.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04301583 COMPLETED
Athletes
Universidad Europea de Madrid
 2020-06-01

(data from https://clinicaltrials.gov, updated on 2020-11-04)

Check the Procyanidin B2 (PCB2) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Procyanidin B2 selectively activates peroxisome proliferator-activated receptor gamma (PPARγ) and suppresses NLRP3 inflammasome activation, thereby driving M2 macrophage polarization and attenuating tissue inflammation. This modulation of cellular metabolic and anti-inflammatory pathways directly underpins its role in promoting mitochondrial biogenesis and physiological recovery in athletic performance contexts.

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.