Clinical Trials

A completed clinical trial investigating trigonelline evaluated healthy human participants to characterize systemic metabolite profiles following coffee consumption. Sponsored through a collaboration between Chalmers University of Technology and Paulig Group, the study operated outside conventional clinical phases. Overall, the clinical evaluation of trigonelline remains focused on nutritional metabolite profiling in healthy cohorts rather than disease-targeted therapeutic trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05757154 Completed
Healthy
Chalmers University of Technology|Paulig Group
 2023-03-31 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Trigonelline inhibits FcεRI-mediated signaling pathways by suppressing the phosphorylation of PLCγ1, PI3K, and Akt, thereby blocking downstream microtubule assembly and cellular degranulation. This biochemical suppression of inflammatory signaling and metabolic pathways provides the therapeutic foundation for its biological effects, connecting directly to clinical studies evaluating nutritional metabolite profiles in healthy cohorts.

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.