Corn Oil Clinical Trials

Clinical Trials

Corn oil has been evaluated in numerous clinical trials spanning Phase 1 through Phase 4 and non-applicable designations to investigate conditions including metabolic syndrome, type 2 diabetes mellitus, insulin resistance, atherosclerosis, and colorectal cancer. Sponsored by academic and medical institutions such as Tufts University, the University of Bologna, and Sheba Medical Center, these studies encompass active, completed, suspended, and terminated statuses. Clinical investigations have assessed the dietary effects of corn oil formulations compared with other lipid sources on vascular risk markers and lipid parameters in human cohorts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07575438	NOT_YET_RECRUITING	Type 2 Diabetes; Prediabetes (Insulin Resistance, Impaired Glucose Tolerance); Prediabetes / Type 2 Diabetes; Obesity & Overweight; Obesity and Diabetes Mellitus, Type 2	May Faraj, PDt, PhD	2026-07	PHASE2
NCT07643558	RECRUITING	Cancer Cachexia; Omega 3; Resistance Training; Cancer; Muscle Wasting; Systemic Inflammation	University of Erlangen-Nürnberg Medical School	2026-01-01
NCT07509229	ENROLLING_BY_INVITATION	Retinitis Pigmentosa	Sheba Medical Center	2026-07-26	PHASE1; PHASE2
NCT05404230	RECRUITING	Peripheral Neuropathy; Colorectal Cancer	Vejle Hospital	2022-07-15
NCT07514663	RECRUITING	Hypercholesterolemia	Midwest Center for Metabolic and Cardiovascular Research	2026-04-10
NCT06720662	NOT_YET_RECRUITING	Atherosclerosis Cardiovascular Disease	University of Sao Paulo	2025-04-01
NCT06129526	UNKNOWN	Diabetes Type 2; Hypertriglyceridemia; Diabetes Mellitus	University of Ioannina	2023-12	PHASE4
NCT05053347	COMPLETED	Elevated Blood Sugar	Huazhong University of Science and Technology	2022-07-01
NCT04920825	COMPLETED	Endocrine and Metabolic Secondary Hypertension	Universiti Sains Malaysia	2021-05-01
NCT05217745	UNKNOWN	Non-Alcoholic Fatty Liver Disease; Non-Alcoholic Steatohepatitis; NAFLD	National University Hospital, Singapore	2021-08-05
NCT05128240	Unknown status	Skin Health	Epax Norway AS\|Møreforsking AS	2021-08-23	Not Applicable
NCT04609423	COMPLETED	Covid-19; Respiratory Tract Infections	Oslo University Hospital	2020-11-10	PHASE4
NCT04069195	UNKNOWN	Inflammation; Pregnancy Related	Walter Reed National Military Medical Center	2019-02-01
NCT01841944	COMPLETED	Myocardial Infarction; Heart Failure; Myocardial Revascularization; Atrial Fibrillation	Oslo University Hospital	2012-11
NCT02104817	COMPLETED	Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)	AstraZeneca	2014-10-30	PHASE3
NCT03115775	COMPLETED	Protein	Washington University School of Medicine	2017-05-12
NCT06061510	COMPLETED	Type 2 Diabetes Mellitus; Lipid Metabolism Disorder; Fatty Acid Metabolism Disorder	Southeast University, China	2019-06-08
NCT03490955	COMPLETED	Black Pepper; Absorption; Carotenoid	University of Massachusetts, Amherst	2018-09-06
NCT03280615	COMPLETED	Renal Insufficiency, Chronic	University of Chile	2017-09-20	PHASE3
NCT02676466	COMPLETED	Inflammation	University of Florida	2016-04-26	PHASE2
NCT03202654	COMPLETED	Healthy Men and Women	Midwest Center for Metabolic and Cardiovascular Research	2017-06-22
NCT03005535	UNKNOWN	Atherosclerosis	University of Bologna	2016-10
NCT02625870	UNKNOWN	Hypertriglyceridemia	Jiangsu HengRui Medicine Co., Ltd.	2015-12	PHASE3
NCT01817634	COMPLETED	Child Malnutrition	University Ghent	2013-11
NCT02346994	COMPLETED	Obesity; Overweight; Pediatric Obesity	Columbia University	2013-01
NCT00982462	COMPLETED	Infant Development	Retina Foundation of the Southwest	2011-01-20
NCT02103517	COMPLETED	Suboptimal Health Status	Chinese PLA General Hospital	2014-09	PHASE3
NCT02308930	UNKNOWN	Healthy	Sun Yat-sen University	2014-07
NCT01560988	COMPLETED	Asthma	Brigham and Women's Hospital	2013-02	PHASE3
NCT01308957	COMPLETED	Sarcopenia	Washington University School of Medicine	2011-06
NCT01107964	COMPLETED	Dry Eye Syndrome	Milton S. Hershey Medical Center	2010-07
NCT01744275	SUSPENDED	Epilepsy	Hospital do Coracao	2013-07	PHASE2; PHASE3
NCT02173587	UNKNOWN	Rheumatoid Arthritis	Zhejiang University	2014-02
NCT01922713	COMPLETED	Vitamin A Deficiency	University of California, Davis	2013-10
NCT01925716	COMPLETED	Hypercholesterolemia	ACH Food Companies, Inc.	2013-03
NCT02006394	COMPLETED	Insulin Resistance; Obesity; Metabolic Syndrome	University of California, San Diego	2012-01
NCT00962598	COMPLETED	Depressive Disorder, Major	Icahn School of Medicine at Mount Sinai	2006-01	PHASE2
NCT00312897	COMPLETED	Adolescent Depression	Icahn School of Medicine at Mount Sinai	2005-12	PHASE2
NCT01720589	COMPLETED	Childhood Obesity	St. Luke's-Roosevelt Hospital Center	2012-10
NCT00680355	COMPLETED	Healthy	Tufts University	2004-08
NCT00891826	COMPLETED	Bipolar Disorders	Ludwig-Maximilians - University of Munich	2009-04
NCT01241474	COMPLETED	Metabolic Syndrome X; Type 2 Diabetes Mellitus; Sarcopenia	University of Aberdeen	2009-02
NCT00806442	COMPLETED	Bronchial Asthma	Brigham and Women's Hospital	2008-12	PHASE1; PHASE2
NCT01806142	COMPLETED	Metabolic Syndrome X	Laval University	2011-02
NCT01191177	WITHDRAWN	Liver Disease; Short Bowel Syndrome	Boston Children's Hospital	2011-01	PHASE1; PHASE2
NCT01049295	UNKNOWN	Breast Cancer	Tehran University of Medical Sciences	2010-04	PHASE4
NCT01155336	TERMINATED	Myocardial Infarction	University of Rochester	2010-06	PHASE1; PHASE2
NCT01145066	COMPLETED	Diabetes; Metabolic Syndrome x	Wake Forest University Health Sciences	2009-05	PHASE2
NCT01634776	COMPLETED	Effect of Fatty Acids on Memory Performance of Toddlers	University of North Carolina, Chapel Hill	2009-02
NCT00794079	COMPLETED	Healthy	Washington University School of Medicine	2007-06
NCT01089231	COMPLETED	Hyperlipidemia; Healthy	Gottfried Wilhelm Leibniz Universität Hannover	2010-03	PHASE4
NCT00116857	COMPLETED	Cardiovascular Diseases; Depression; Heart Diseases; Myocardial Infarction; Angina, Unstable	Washington University School of Medicine	2005-02	PHASE3
NCT00504309	COMPLETED	Hypertriglyceridemia	Penn State University	2007-07
NCT00678925	COMPLETED	Healthy	The Gerber Foundation	2004-12
NCT00571948	COMPLETED	Iron Status; Fatty Acid Status	Research Institute of Child Nutrition, Dortmund	2005-09
NCT01422317	COMPLETED	Coronary Disease; Myocardial Infarction	Helse Stavanger HF	1995-09	PHASE3

(data from https://clinicaltrials.gov, updated on 2026-05-12)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a hydrophobic lipid carrier rich in polyunsaturated fatty acids, corn oil interacts with cellular membranes to alter lipid bilayer fluidity and facilitate the partitioning of fat-soluble compounds. This membrane integration promotes the solubilization and cellular bioavailability of lipophilic molecules, establishing its therapeutic relevance as a control vehicle and nutritional intervention in clinical studies investigating metabolic syndrome, atherosclerosis, and lipid metabolism 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>).