Clinical Trials

Numerous clinical trials evaluate the therapeutic potential and biological activity of hydroxytyrosol across Phase 1 through Phase 4 studies encompassing completed, recruiting, active, and withdrawn statuses. Sponsored primarily by academic and medical institutions, these studies investigate conditions including non-alcoholic fatty liver disease, cardiovascular disease, endothelial dysfunction, visceral obesity, mitochondrial diseases, metabolic disorders, type 2 diabetes, and pediatric fatty liver disorders. This research reflects broad clinical interest in the compound's antioxidant, metabolic, and vascular protective effects.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07672938 RECRUITING
Mild Cognitive Impairment (MCI)
Panhellenic Federation of Alzheimer's Disease and Related Disorders
 2025-03-31
NCT07689214 RECRUITING
Diabete Type 2
University of Roma La Sapienza
 2024-07-17
NCT06833866 RECRUITING
Advanced or Metastatic CRC
The Methodist Hospital Research Institute
 2024-12-04 PHASE1
NCT07298759 COMPLETED
Hypertension in Pregnancy
Dr Cipto Mangunkusumo General Hospital
 2025-06-11
NCT06992323 ACTIVE_NOT_RECRUITING
Hypertriglyceridemia; Normal
National Research Council, Spain
 2025-02-17
NCT07074548 COMPLETED
Hypertension in Pregnancy
Dr Cipto Mangunkusumo General Hospital
 2025-07-10
NCT04520126 UNKNOWN
Coronary Artery Disease
University of Athens
 2020-12-01
NCT06954649 COMPLETED
Cholesterol Lowering; LDL Level
Centro de Edafología y Biología Aplicada del Segura
 2025-01-14
NCT06735222 COMPLETED
Healthy; Young
National Research Council, Spain
 2024-11-18
NCT06295913 COMPLETED
Overweight; PreDiabetes
National Research Council, Spain
 2023-12-01
NCT04543968 COMPLETED
Mitochondrial Diseases
Hong Kong Children's Hospital
 2022-07-05
NCT06285682 COMPLETED
Healthy
Anglia Ruskin University
 2024-02-03
NCT05472753 COMPLETED
Colon Cancer
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
 2022-11-16
NCT05485402 COMPLETED
Sarcopenia
University Rovira i Virgili
 2022-09-01
NCT06319417 COMPLETED
Cardiovascular Pathology
Universidad Católica San Antonio de Murcia
 2022-04-15
NCT05679310 COMPLETED
Oxidative Stress; Inflammation; Body Weight; Homocystine; Metabolic Disorder
University of Ioannina
 2022-02-10
NCT04899791 COMPLETED
Type 2 Diabetes Mellitus; Obesity
Harokopio University
 2021-05-24
NCT04876261 COMPLETED
Biological Availability
Daacro
 2021-05-10
NCT02068092 COMPLETED
Breast Cancer
The Methodist Hospital Research Institute
 2013-12 PHASE2; PHASE3
NCT04725955 COMPLETED
Postprandial Responses
Harokopio University
 2021-01-31
NCT04317079 COMPLETED
Body Weight; Visceral Obesity
National and Kapodistrian University of Athens
 2017-10-30
NCT02842567 COMPLETED
NAFLD
Bambino Gesù Hospital and Research Institute
 2017-04-01 PHASE3
NCT01381354 COMPLETED
Multiple Sclerosis
University of Iowa
 2010-10 PHASE1
NCT02273622 COMPLETED
Healthy
IMDEA Food
 2014-10
NCT01983943 WITHDRAWN
Cardiovascular Disease; Endothelial Function
Mayo Clinic
 2013-08
NCT02042742 COMPLETED
Healthy
Instituto de Investigación Hospital Universitario La Paz
 2013-04 PHASE4
NCT01790672 COMPLETED
Contribution of Wine Components in Hydroxytyrosol Formation
Parc de Salut Mar
 2011-05 PHASE1
NCT01788670 COMPLETED
Contribution of Ethanol on Hydroxytyrosol Formation
Parc de Salut Mar
 2009-05 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-06-30)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Hydroxytyrosol directly scavenges reactive oxygen species and inhibits key pro-inflammatory signaling cascades, including NF-κB pathway activation, thereby protecting cells from oxidative stress and reducing lipid peroxidation. This reduction in intracellular oxidative damage and inflammatory injury provides the biological rationale for its clinical evaluation in conditions such as non-alcoholic fatty liver disease, metabolic disorders, and cardiovascular dysfunction.

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>).

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Note: Technical data last updated: Sep 1, 2026.