Clinical Trials

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)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Stearic acid is a long-chain saturated fatty acid that incorporates into cellular membranes and metabolic lipid pools, influencing membrane fluidity, lipid raft architecture, and intracellular signaling cascades involved in lipid oxidation and triglyceride synthesis. By modulating hepatic lipid processing and circulating lipoprotein metabolism, its administration impacts postprandial lipemia and lipid profiles, which is directly relevant to clinical evaluations targeting dyslipidemia, cardiometabolic health, and cardiovascular disease risk.

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.