Numerous clinical trials evaluate palmitic acid across diverse conditions, including obesity, type 2 diabetes, hyperlipidemia, prostate cancer, raised fasting plasma triacylglycerols, and infant weight gain, with emphasis on dietary fatty acid metabolism and postprandial lipemic responses. Spanning Phase 2 to Phase 4 as well as unclassified study designs, these trials encompass completed, recruiting, active not recruiting, and terminated recruitment statuses. Research is sponsored by academic institutions, industry entities such as Enzymotec, and government agencies, including the National Cancer Institute and the National Institute of Diabetes and Digestive and Kidney Diseases.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06683534 | NOT_YET_RECRUITING | Microvascular Dysfunction; Microvasculature; Cardiovascular Diseases; Cardiovascular Diseases (CVD); Microvascular Health; Obesity and Overweight |
Medical College of Wisconsin |
2026-07 | PHASE2 |
| NCT06192407 | RECRUITING | Aging |
University of Vermont |
2024-04-15 | |
| NCT07766915 | NOT_YET_RECRUITING | CVD Risk |
Tufts University |
2026-09 | |
| 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 |
| NCT04541095 | Recruiting | Weight Gain |
Ospedali Riuniti Ancona|Istituto di Ricerca Pediatrica Città della Speranza|Bunge Loders Croklaan |
2023-01-16 | Not Applicable |
| NCT04418102 | COMPLETED | Cardiometabolic Health |
King's College London |
2020-02-01 | |
| NCT03665922 | Active not recruiting | Prostate Cancer |
University of Pittsburgh|National Cancer Institute (NCI) |
2019-05-01 | Not Applicable |
| NCT05791370 | Completed | Diet|Healthy |
Malaysia Palm Oil Board|Universiti Putra Malaysia |
2019-01-01 | Not Applicable |
| NCT04832217 | Completed | Body Weight Changes|Habits Diet|Habit Food|Life Change Events |
Universidad de Zaragoza |
2019-01-20 | Not Applicable |
| NCT02835651 | COMPLETED | Dyslipidemia |
Maastricht University Medical Center |
2016-04-14 | |
| NCT01428960 | COMPLETED | Healthy |
Malaysia Palm Oil Board |
2011-06 | |
| NCT02332967 | COMPLETED | Healthy Newborn Infants |
Société des Produits Nestlé (SPN) |
2007-07 | |
| NCT01710280 | COMPLETED | Healthy Men; Raised Fasting Plasma Triacylglycerol Concentrations |
King's College London |
2011-05 | |
| NCT01116115 | COMPLETED | Health Behavior; Disorder of Growth and Development |
Enzymotec |
2010-04 | |
| NCT00874068 | COMPLETED | Personal Satisfaction |
Enzymotec |
2009-02 | |
| NCT01066091 | COMPLETED | Healthy; Obesity |
Yves Boirie |
2010-03 | |
| NCT00480948 | TERMINATED | Healthy |
Enzymotec |
2008-09 | PHASE4 |
| NCT00059254 | COMPLETED | Obesity; Diabetes; Hyperlipidemia |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
2000-09 |
(data from https://clinicaltrials.gov, updated on 2026-04-29)
Mechanism and Biochemical Profile
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>).