Clinical Trials

Multiple clinical trials assess antioxidant status and metabolic outcomes associated with ABTS substrate applications in periodontitis, postprandial hyperglycemia, obesity, chronic hepatitis C, metabolic syndrome, and healthy cohorts. Evaluating dietary interventions rather than pharmaceuticals, these protocols report a phase status of Not Applicable and encompass both completed studies and those with unknown recruitment status. These initiatives are sponsored by academic and clinical institutions, including the University of Milan, São Paulo State University, Egas Moniz Cooperativa de Ensino Superior, and the Buchinger Wilhelmi Clinic.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05449249 Completed
Healthy|Periodontitis
Buchinger Wilhelmi Development & Holding GmbH|Buchinger Wilhelmi Clinic|University of Geneva Switzerland|King''s College London|ETH Zurich (Switzerland)
 2022-09-01 Not Applicable
NCT04053569 Unknown status
Metabolic Syndrome Protection Against
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
 2019-10-01 Not Applicable
NCT03935022 Completed
Healthy
University of Milan
 2019-03-06 Not Applicable
NCT05140629 Completed
Hyperglycemia Postprandial
Egas Moniz - Cooperativa de Ensino Superior CRL
 2017-01-02 Not Applicable
NCT02914249 Completed
Obesity
São Paulo State University|National Association of Exporters of Citrus Juices|Citrosuco Company
 2015-09 Not Applicable
NCT03026569 Completed
Chronic Infection
São Paulo State University
 2012-05 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

ABTS serves as a chromogenic substrate that binds to horseradish peroxidase, undergoing single-electron oxidation to generate a stable radical cation with strong visible absorbance. This enzyme-catalyzed oxidation enables precise quantification of free radical scavenging capacity, facilitating the assessment of systemic antioxidant potential in clinical trial settings investigating obesity, postprandial hyperglycemia, 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.