Millet Extract Clinical Trials

Size	Price	Qty
5mg	USD 89

Clinical Trials

Multiple clinical trials evaluate the therapeutic and nutritional potential of millet extract, focusing on clinical conditions such as human microbiome modulation, systemic inflammation, and nutritional deficiencies. With trial phases categorized as Not Applicable due to the food-based nature of the interventions, these studies encompass both recruiting and completed recruitment statuses. Supported by academic universities, research institutes, and non-profit organizations including Ghent University, HarvestPlus, and the Bill and Melinda Gates Foundation, this research quantifies physiological impacts on gut microbial diversity, inflammatory biomarkers, and micronutrient bioavailability.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05299970	Recruiting	Inflammation\|Microbiome Human	Institut de Recherche en Sciences de la Sante Burkina Faso\|University Ghent\|Bill and Melinda Gates Foundation	2022-03-21	Not Applicable
NCT01783067	Completed	Nutritional Deficiency	University of Colorado Denver\|Jawaharlal Nehru Medical College\|HarvestPlus\|International Atomic Energy Agency	2011-02	Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rich in polyphenols and dietary fibers, Millet Extract scavenges reactive oxygen species and suppresses pro-inflammatory signaling pathways to attenuate cellular oxidative damage. Furthermore, these bioactive constituents function as prebiotics that modulate gut microbial composition and optimize trace element absorption, directly supporting its clinical evaluation for managing inflammation, human microbiome health, and nutritional deficiencies.

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>).