Multiple clinical trials evaluate the metabolic and cardiovascular effects of stearic acid and related dietary lipids, focusing on conditions such as cardiometabolic health, dyslipidemia, cardiovascular disease risk, metabolic syndrome, and idiopathic triglyceride deposit cardiomyovasculopathy. Supported predominantly by academic institutions, medical centers, and agricultural research organizations, these studies encompass non-phased dietary interventions alongside early Phase 1/Phase 2 trials. Across these protocols, recruitment statuses range from completed studies to those currently listed as unknown or not yet recruiting.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07766915 | NOT_YET_RECRUITING | CVD Risk |
Tufts University |
2026-09 | |
| NCT04418102 | COMPLETED | Cardiometabolic Health |
King's College London |
2020-02-01 | |
| NCT04053569 | Unknown status | Metabolic Syndrome Protection Against |
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis |
2019-10-01 | Not Applicable |
| NCT04832217 | Completed | Body Weight Changes|Habits Diet|Habit Food|Life Change Events |
Universidad de Zaragoza |
2019-01-20 | Not Applicable |
| NCT02835651 | COMPLETED | Dyslipidemia |
Maastricht University Medical Center |
2016-04-14 | |
| NCT02502578 | Completed | Idiopathic Triglyceride Deposit Cardiomyovasculopathy |
Osaka University |
2015-09 | Phase 1|Phase 2 |
| NCT01428960 | COMPLETED | Healthy |
Malaysia Palm Oil Board |
2011-06 |
(data from https://clinicaltrials.gov, updated on 2026-08-17)
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>).