Multiple clinical trials evaluate interventions for conditions such as insulin resistance, coronary artery disease, acute lung injury, masticatory dysfunction, post-exercise energy intake, and peripheral vasoconstriction disorders. These studies encompass Phase I protocols investigating whole-body glucose metabolism alongside non-phased trials examining tissue perfusion, masticatory performance, and autonomic vagus nerve stimulation. Supported by academic and healthcare institutions including the National Institute on Aging and the Federal University of São Paulo, their recruitment statuses currently include completed, terminated, and unknown.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07050017 | COMPLETED | Appetite; Energy Intake; Post-exercise; Negative Energy Balance |
Hacettepe University |
2025-05-29 | |
| NCT05173259 | COMPLETED | Chewing Problem; Mastication Disorder |
University of Barcelona |
2021-12-01 | |
| NCT03753022 | UNKNOWN | Coronary Artery Disease; Coronary Artery Bypass Grafting; Acute Lung Injury |
Federal University of São Paulo |
2012-01 | |
| NCT04130893 | TERMINATED | Vasoconstriction Disorder of Extremities |
Hôpital Européen Marseille |
2019-01-17 | |
| NCT02518932 | UNKNOWN | Insulin Resistance |
Elahi, Dariush, PhD |
2015-03 | PHASE1 |
| NCT02518932 | Unknown status | Insulin Resistance |
Elahi Dariush PhD|ICON plc|Massachusetts General Hospital|National Institute on Aging (NIA) |
2015-03 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2025-10-06)
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>).