Clinical Trials

Numerous clinical trials evaluate the therapeutic and physiological effects of oleic acid across nutritional and metabolic disorders, including parenteral nutrition-associated liver disease, essential fatty acid deficiency, malnutrition, obesity, metabolic syndrome, hypercholesterolemia, diabetes, and cardiovascular risk. Spanning Phase 1, 2, and 4 trials alongside non-interventional dietary interventions, recruitment statuses encompass completed, active non-recruiting, recruiting, and not-yet-recruiting protocols. These studies are sponsored by government organizations such as the NIDDK, academic institutions like Yale University, and pharmaceutical partners including Fresenius Kabi.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06361511 RECRUITING
Sarcopenia
Ohio State University
 2025-04-16
NCT06192407 RECRUITING
Aging
University of Vermont
 2024-04-15
NCT07027033 RECRUITING
Obesity; Visceral Adipose Tissue; White Adipose Tissue Inflammation; Subcutaneous Adipose Tissue
Nantes University Hospital
 2025-07-15
NCT02841618 ACTIVE_NOT_RECRUITING
Healthy Adults
Ohio State University
 2016-01
NCT06723886 RECRUITING
Type 2 Diabetes Mellitus; Prediabetes (Insulin Resistance, Impaired Glucose Tolerance); Prediabetic State; Diabetes; Diabetes Mellitus
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
 2025-01-15
NCT06172335 RECRUITING
Metabolic Syndrome
Oslo University Hospital
 2024-01-03
NCT04531410 COMPLETED
Cystic Fibrosis
Karolinska Institutet
 2021-10-25
NCT06274788 Not yet recruiting
Parenteral Nutrition Associated Liver Disease (PNALD)|Essential Fatty Acid Deficiency|Malnutrition|Pediatric ALL
Fresenius Kabi
 2024-05-01 Phase 4
NCT05556967 Completed
Adherence Patient
University of Mississippi Medical Center|University of Mississippi National Center for Natural Products Research|National Center for Complementary and Integrative Health (NCCIH)
 2023-08-09 Not Applicable
NCT05444842 UNKNOWN
Diabetes Mellitus
Cairo University
 2022-07-05
NCT03625427 COMPLETED
Chronic Inflammation; Overweight
University of North Carolina, Chapel Hill
 2019-09-26
NCT04841044 UNKNOWN
Healthy Diet
University of Oslo
 2021-04-27
NCT04614233 Active not recruiting
Overweight and Obesity
Yale University|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2021-04-06 Phase 4
NCT03739463 UNKNOWN
PPROM
Université de Sherbrooke
 2018-12-03
NCT04053569 Unknown status
Metabolic Syndrome Protection Against
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
 2019-10-01 Not Applicable
NCT05791370 Completed
Diet|Healthy
Malaysia Palm Oil Board|Universiti Putra Malaysia
 2019-01-01 Not Applicable
NCT04997122 COMPLETED
Healthy; Hypercholesterolemia
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
 2018-04-02
NCT04641494 COMPLETED
Obesity; Lung Functions; Inflammation; Lipid Disorder
University of Chester
 2016-11-11
NCT01661764 COMPLETED
Colorectal Adenomatous Polyps
Vanderbilt University
 2013-02-04 PHASE2
NCT02029833 COMPLETED
Cardiovascular Disease; Diabetes; Metabolic Syndrome
University of Manitoba
 2013-03
NCT03054779 COMPLETED
Cardiovascular Disease; Metabolic Syndrome
Penn State University
 2014-09
NCT00638196 TERMINATED
Multiple Sclerosis
University of Rochester
 2008-03 PHASE1
NCT01351012 COMPLETED
Metabolic Syndrome
University of Manitoba
 2010-09
NCT01233778 COMPLETED
Cardiovascular Disease
Penn State University
 2010-10
NCT01365078 COMPLETED
Lipid Metabolism Disorders
Maastricht University Medical Center
 2011-07
NCT01674946 COMPLETED
Echolocation
University Hospital, Basel, Switzerland
 2011-09 PHASE1
NCT01066091 COMPLETED
Healthy; Obesity
Yves Boirie
 2010-03
NCT01043445 COMPLETED
Type 2 Diabetes
Glostrup University Hospital, Copenhagen
 2009-09
NCT01124487 COMPLETED
Lipid Profile
Malaysia Palm Oil Board
 2009-08
NCT00715312 COMPLETED
Inflammation
Malaysia Palm Oil Board
 2008-02
NCT01042340 COMPLETED
Nutritional Intervention
Karolinska University Hospital
 2005-12
NCT00059254 COMPLETED
Obesity; Diabetes; Hyperlipidemia
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2000-09
NCT00535886 COMPLETED
Cardiovascular Disease; Diabetes; Dyslipidemia
UCSF Benioff Children's Hospital Oakland
 2005-11

(data from https://clinicaltrials.gov, updated on 2026-04-21)

Check the Oleic acid (cis-9-Octadecenoic acid) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Oleic acid acts as an abundant monounsaturated fatty acid that directly activates the Na+/K+ ATPase pump and incorporates into membrane phospholipids, modulating cell membrane fluidity and lipid-mediated signaling cascades. This activation regulates intracellular ion homeostasis and systemic lipid transport, which provides therapeutic relevance in clinical trial conditions such as metabolic syndrome, hypercholesterolemia, and parenteral nutrition-associated liver disease.

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.