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)
Mechanism and Biochemical Profile
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>).