Numerous clinical trials evaluate the therapeutic and dietary impacts of phytosterols in pediatric malnutrition alongside metabolic and cardiovascular diseases, including hypercholesterolemia, familial hypercholesterolemia, dyslipidemia, non-alcoholic fatty liver disease, and coronary heart disease. Ranging from Early Phase 1 through Phase 4 as well as unassigned nutritional evaluations, these studies are sponsored by academic medical centers and industrial organizations. Across these initiatives, operational statuses vary, encompassing completed, active not recruiting, terminated, and withdrawn trials.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06331195 | ACTIVE_NOT_RECRUITING | Familial Hypercholesterolemia |
Hospital do Coracao |
2024-10-23 | |
| NCT06697977 | COMPLETED | NAFLD; Insulin Resistance; Metabolic Syndrome; Obesity; Diabetes; Nash; Dyslipidemias |
University of Jordan |
2023-08-15 | |
| NCT06954649 | COMPLETED | Cholesterol Lowering; LDL Level |
Centro de Edafología y Biología Aplicada del Segura |
2025-01-14 | |
| NCT06340308 | UNKNOWN | Dyslipidemias |
University of Pavia |
2023-06-07 | |
| NCT03563222 | Terminated | Malnutrition Child |
Fresenius Kabi |
2019-12-18 | Phase 4 |
| NCT02969720 | COMPLETED | Metabolic Syndrome x |
Universidad de los Andes, Chile |
2018-01-08 | |
| NCT06127732 | COMPLETED | Hypercholesterolemia; Primary Prevention |
Federal University of São Paulo |
2017-05-01 | |
| NCT03065491 | COMPLETED | Hypercholesterolemia |
University of Bologna |
2016-11-15 | |
| NCT02644109 | COMPLETED | Dyslipidemias; Hypercholesterolemia |
University of Chile |
2015-10 | PHASE4 |
| NCT02603276 | COMPLETED | Hypercholesterolemia |
University of Bologna |
2015-04 | |
| NCT02065024 | COMPLETED | Hypercholesterolemia; Osteoporosis |
Puerta de Hierro University Hospital |
2014-03 | PHASE1 |
| NCT02268318 | COMPLETED | Subjects With High LDL-Cholesterol |
Danone Japan |
2014-01 | |
| NCT02278393 | COMPLETED | Healthy Volunteers |
Danone Japan |
2014-02 | |
| NCT02065024 | Completed | Hypercholesterolemia|Osteoporosis |
Puerta de Hierro University Hospital |
2014-03 | Phase 1 |
| NCT02758834 | Completed | Liver Diseases |
Università Politecnica delle Marche |
2014-01 | -- |
| NCT02947594 | Completed | Liver Disease |
Università Politecnica delle Marche |
2014-01 | -- |
| NCT01074723 | COMPLETED | Postmenopausal Disorder |
Puerta de Hierro University Hospital |
2010-02 | PHASE1 |
| NCT00720720 | WITHDRAWN | Hypercholesterolemia |
French Cardiology Society |
2009-12-16 | |
| NCT00863265 | COMPLETED | Hypercholesterolemia; Coronary Heart Disease |
Washington University School of Medicine |
2009-06 | EARLY_PHASE1 |
| NCT00860054 | COMPLETED | Hypercholesterolemia; Coronary Heart Disease |
Washington University School of Medicine |
2006-03 | |
| NCT01600820 | COMPLETED | Hypercholesterolemia |
Danone Spain |
2005-02 |
(data from https://clinicaltrials.gov, updated on 2026-05-12)
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>).