Clinical Trials

Several clinical trials involve triolein to evaluate conditions such as obesity, exocrine pancreatic insufficiency, atherosclerosis, and metabolic processes including oral fat perception, fecal lipid elimination, and vascular monocyte responses. Sponsored by academic centers—such as Washington University School of Medicine, Mayo Clinic, Corporacion Parc Tauli, and Imperial College London—alongside industry partners like GlaxoSmithKline, these studies feature unassigned or unspecified trial phases. Recorded recruitment statuses for these investigations include both completed and terminated trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03002168 COMPLETED
Healthy Participants
Mayo Clinic
2017-01-20
NCT02101346 TERMINATED
Atherosclerosis
Imperial College London
2014-10
NCT01128400 Completed
Obesity
Washington University School of Medicine|GlaxoSmithKline
2010-05 --

(data from https://clinicaltrials.gov, updated on 2017-11-17)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Triolein acts as an inhibitor of matrix metalloproteinase-1 (MMP-1), thereby suppressing downstream reactive oxygen species generation and downregulating interleukin-6 expression at the cellular level. By mitigating oxidative stress, tissue degradation, and inflammatory mediator signaling, this molecular activity provides a mechanistic rationale for clinical investigations into metabolic and vascular disorders such as obesity and atherosclerosis.

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>).

Note: Technical data last updated: Sep 1, 2026.