Clinical Trials

Several clinical trials investigate the physiological and therapeutic potential of the citrus flavanone hesperetin, focusing on metabolic syndrome, vascular compliance, blood glucose regulation, hunger management, cardiovascular disease risk, and athletic performance. Sponsored predominantly by academic and research organizations such as the University of Vienna and Chalmers University of Technology, these studies consist primarily of early phase 1 and phase not applicable designs. The trial portfolio displays varied recruitment statuses, including completed, active not recruiting, and unknown status.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07104734 COMPLETED
Healthy; Athletes
China Medical University Hospital
 2024-09-03
NCT06340087 COMPLETED
Blood Glucose Fluctuations; Hunger
University of Vienna
 2024-03-31 EARLY_PHASE1
NCT05705596 COMPLETED
Blood Glucose Fluctuations; Hunger
University of Vienna
 2023-01-31 EARLY_PHASE1
NCT05073523 Completed
Healthy
Chalmers University of Technology
 2021-09-27 Not Applicable
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
NCT02380144 Unknown status
Healthy
University of Hohenheim
 2014-01 Not Applicable
NCT02627547 Completed
Healthy
University of Glasgow
 2013-09 Not Applicable

(data from https://clinicaltrials.gov, updated on 2025-08-05)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Hesperetin acts by suppressing acyl-CoA:cholesterol acyltransferase 2 mRNA transcription and reducing apolipoprotein B synthesis in hepatocytes, while simultaneously inhibiting IgE-mediated histamine release. These cellular actions attenuate lipid accumulation and inflammatory signaling, providing a biochemical mechanism relevant to its clinical evaluation in managing blood glucose fluctuations, vascular compliance, and metabolic syndrome.

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.