Cafestol Clinical Trials

Size	Price	Qty
1mg	USD 219

Clinical Trials

A clinical trial evaluated the acute physiological effects of cafestol administration on glucose metabolism in participants with type 2 diabetes mellitus. Sponsored by academic and medical institutions, including Aarhus University and Aarhus University Hospital, this completed study investigated key metabolic parameters. With a phase status classified as Not Applicable, the trial served as an exploratory investigation rather than a conventional phase-based efficacy study.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04908904	Completed	Diabetes Mellitus Type 2	University of Aarhus\|Aarhus University Hospital	2021-05-27	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cafestol modulates cellular signaling by inhibiting the PI3K/Akt pathway and decreasing reactive oxygen species generation, thereby downregulating inflammatory mediator expression and inducing cell apoptosis. This inhibition of signaling cascades and modulation of cellular metabolic stress provide a mechanistic rationale for evaluating cafestol in therapeutic research targeting metabolic disorders such as 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>).