Olive oil Clinical Trials

Size	Price	Qty
100mg	USD 97

Clinical Trials

Several clinical trials sponsored by academic and medical institutions, including Assistance Publique - Hôpitaux de Paris, Bangabandhu Sheikh Mujib Medical University, and Cairo University, are evaluating olive oil for Type 2 diabetes, neonatal weight gain, and autoimmune skin disorders such as pemphigus vulgaris and bullous pemphigoid. Incorporating Phase 3, unclassified, and phase-not-applicable protocols, these studies encompass both completed evaluations of neonatal growth parameters and actively recruiting trials investigating dietary adherence in diabetes and topical ozonated formulations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05292833	Recruiting	Type 2 Diabetes	Assistance Publique - Hôpitaux de Paris	2023-07-06	--
NCT05944991	Completed	Weight Gain	Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh	2022-12-01	Not Applicable
NCT05594472	Recruiting	Pemphigus Vulgaris\|Bullous Pemphigoid	Cairo University	2022-11-01	Phase 3

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Olive oil constituents modulate oxidative stress pathways and suppress pro-inflammatory signaling cascades within targeted tissues. By attenuating cellular reactive oxygen species production and inflammatory mediator release, olive oil helps maintain cellular homeostasis, providing a biological rationale for its therapeutic evaluation in metabolic conditions like Type 2 diabetes and cutaneous inflammatory disorders.

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>).