Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 investigate soybean oil across diverse conditions, including metabolic disorders, insulin sensitivity, inflammatory responses during cardiac surgery, depressive symptoms, enteral nutrition, and cardiovascular risk markers. Sponsored by both academic institutions and industry entities, these protocols reflect a range of recruitment statuses, from active and recruiting to completed, terminated, and withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06736925 RECRUITING
Subconcussive Head Impact; Omega-3 Fatty Acids
Indiana University
 2025-02-28
NCT07462013 RECRUITING
Major Depressive Disorder (MDD)
National Science and Technology Council, Taiwan
 2025-10-01
NCT04349475 ACTIVE_NOT_RECRUITING
Pregnancy
University of Colorado, Denver
 2021-11-29
NCT05199948 ACTIVE_NOT_RECRUITING
Nonalcoholic Fatty Liver
Ohio State University
 2022-05-02
NCT06245083 WITHDRAWN
Maternal Obesity
University of Oklahoma
 2024-12 EARLY_PHASE1
NCT04975763 ACTIVE_NOT_RECRUITING
Overweight and Obesity
Ohio State University
 2021-07-19
NCT06294067 COMPLETED
Nutrition, Healthy
University of Toronto
 2024-02-26 PHASE1
NCT05278910 UNKNOWN
Inflammation
Academia Sinica, Taiwan
 2022-03-14
NCT02512718 COMPLETED
Hematopoietic Stem Cell Transplantation
Alexandra N. Carey
 2016-06 PHASE1
NCT04555044 COMPLETED
Essential Fatty Acid Deficiency (EFAD)
Baxter Healthcare Corporation
 2021-01-22 PHASE4
NCT04120220 TERMINATED
Overweight
USDA Grand Forks Human Nutrition Research Center
 2019-11-12
NCT03122912 TERMINATED
Aging Problems
University of Michigan
 2018-01-24 PHASE1
NCT04069195 UNKNOWN
Inflammation; Pregnancy Related
Walter Reed National Military Medical Center
 2019-02-01
NCT03857646 COMPLETED
Prematurity
The University of Texas Health Science Center, Houston
 2019-03-02 PHASE4
NCT04586608 COMPLETED
Premature Birth
Iaso Maternity Hospital, Athens, Greece
 2018-02-15
NCT03295708 UNKNOWN
Major Depressive Disorder
Second Xiangya Hospital of Central South University
 2017-10-01
NCT02897674 COMPLETED
Healthy Volunteers
Imperial College London
 2016-02
NCT03742492 UNKNOWN
Healthy Volunteers
Universidade do Porto
 2018-09-19 PHASE2
NCT05972798 COMPLETED
Late Life Depression
Chang Gung Memorial Hospital
 2018-09-25
NCT03638661 COMPLETED
Enteral Nutrition
Yonsei University
 2015-08-11
NCT02550860 TERMINATED
Intestinal Diseases
Hospices Civils de Lyon
 2015-01 PHASE3
NCT01625195 COMPLETED
Healthy
Université de Sherbrooke
 2012-05-01
NCT02924896 COMPLETED
Lipidaemia
Imperial College London
 2016-09
NCT02476994 TERMINATED
Essential Fatty Acid Deficiency (EFAD)
Baxter Healthcare Corporation
 2015-05 PHASE4
NCT02337231 COMPLETED
Genetic Differences of Lipid Metabolism/Healthy Subjects
Wake Forest University Health Sciences
 2014-06-24
NCT02663453 COMPLETED
Cholestasis
Thammasat University
 2013-12 PHASE3
NCT02404207 COMPLETED
Cardiovascular Disease; Diabetes; Metabolic Syndrome
USDA Beltsville Human Nutrition Research Center
 2015-03
NCT02599103 COMPLETED
Colorectal Neoplasms
Academia Sinica, Taiwan
 2013-09
NCT01565278 TERMINATED
Total Parenteral Nutrition-induced Cholestasis
Johane Allard
 2012-02 PHASE3
NCT02802150 COMPLETED
Dry Eye Syndromes
Chonbuk National University Hospital
 2015-02
NCT01814956 TERMINATED
Parenteral Nutrition
B. Braun Melsungen AG
 2013-03 PHASE4
NCT01585246 COMPLETED
Prostate Cancer
Michigan State University
 2011-10 PHASE1; PHASE2
NCT02557698 COMPLETED
Xerosis Cutis
Charite University, Berlin, Germany
 2014-11
NCT02192047 COMPLETED
Overweight
Malaysia Palm Oil Board
 2012-09
NCT01875510 COMPLETED
Retinopathy of Prematurity; Neonatal Cholestasis
Dr. Sami Ulus Children's Hospital
 2013-01
NCT01614249 COMPLETED
Depressive Symptoms
University of Nairobi
 2012-06
NCT01747668 COMPLETED
Lactation
Abbott Nutrition
 2012-11 PHASE3
NCT02199821 COMPLETED
Bone Narrow Transplantation
Maimónides Biomedical Research Institute of Córdoba
 2011-02
NCT01235130 COMPLETED
Atrial Fibrillation
Montreal Heart Institute
 2009-03 PHASE3
NCT02194673 COMPLETED
Healthy
Malaysia Palm Oil Board
 2012-01
NCT01250275 COMPLETED
Peripheral Arterial Disease
University of Manitoba
 2011-09
NCT00663871 COMPLETED
Cardiovascular Diseases; Mood Disorders; Inflammation
University of Pittsburgh
 2008-06
NCT02185729 COMPLETED
Diseases, Metabolic; Insulin Sensitivity
Emory University
 2008-06 PHASE2; PHASE3
NCT01749202 COMPLETED
Sudden Cardiac Death; Sudden Cardiac Arrest; Cardiovascular Disease
Solae, LLC
 2010-08
NCT01369550 COMPLETED
Healthy Volunteers; Markers of Cardiovascular Risk
Monsanto Company, LLC
 2010-08
NCT00672854 COMPLETED
Parenteral Nutrition
Emory University
 2008-11 PHASE2; PHASE3
NCT01006174 COMPLETED
Absorption of Carotenoids From Vegetables
Purdue University
 2009-03
NCT02867488 COMPLETED
Biological Availability
Iowa State University
 2009-04
NCT00579540 COMPLETED
Polycystic Ovarian Syndrome
University of California, Davis
 2007-09
NCT00644098 COMPLETED
People Who Are Overweight or Obesity
Canadian Center for Functional Medicine
 2008-09 PHASE2
NCT00655902 COMPLETED
Metabolic Syndrome; Abdominal Obesity; Heart Disease; Type 2 Diabetes
University of Copenhagen
 2008-04
NCT00600912 COMPLETED
Inflammatory Response; Hepatic Function
Klinikum Ludwigshafen
 2006-12 PHASE4
NCT00892684 UNKNOWN
Allergies
Linkoeping University
 2003-03
NCT00336908 COMPLETED
Inflammation; Cardiac Surgical Procedures
University of Alberta
 2005-11 PHASE2; PHASE3

(data from https://clinicaltrials.gov, updated on 2026-04-29)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Soybean oil supplies essential long-chain fatty acids, primarily linoleic and oleic acids, which integrate into host cell membrane phospholipids and modulate lipid-derived signaling cascades. This incorporation alters membrane fluidity and attenuates pro-inflammatory mediator production, providing crucial caloric support and mitigating systemic inflammation in metabolic disorders and nutritional management.

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.