Steviol (Hydroxydehydrostevic acid) Clinical Trials

Size	Price	Qty
1mg	USD 119
5mg	USD 317

Clinical Trials

Multiple completed clinical trials, sponsored by industry and academic institutions including Cargill, INQUIS Clinical Research, and Universitaire Ziekenhuizen KU Leuven, have evaluated the physiological effects of steviol derivatives across Phase 1 and unclassified trial phases. This research investigated acute glycemic responses during glucose tolerance testing in type 2 diabetes mellitus patients as well as intestinal microbiota changes following steviol glycoside ingestion in healthy adults.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05264636	Completed	Healthy\|Human Gut Microflora	Cargill\|INQUIS Clinical Research	2022-02-15	Not Applicable
NCT03510624	Completed	Type 2 Diabetes Mellitus	Universitaire Ziekenhuizen KU Leuven	2018-11-09	Phase 1

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

Check the Steviol (Hydroxydehydrostevic acid) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Steviol directly inhibits cystic fibrosis transmembrane conductance regulator (CFTR) activity while simultaneously suppressing aquaporin-2 (AQP2) expression and promoting its degradation, thereby altering cellular fluid balance and ion transport across epithelial membranes. This pharmacological modulation of membrane transport proteins provides a mechanistic framework for evaluating gastrointestinal microflora dynamics and metabolic responses in type 2 diabetes mellitus.

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>).