Erythritol Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Multiple clinical trials with non-applicable phase classifications evaluate the biological and physiological impacts of erythritol on conditions such as irritable bowel syndrome, cardiovascular diseases, endotoxemia, endothelial dysfunction, and postprandial hyperglycemia. Sponsored by institutions including Örebro University Sweden, Ohio State University, and the Alliance for Potato Research and Education, these studies feature recruitment statuses ranging from completed to unknown. Specific research focus areas encompass intestinal barrier function as well as cardiometabolic parameters along the gut-vessel axis.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03986476	Completed	IBS	Örebro University Sweden	2019-03-26	Not Applicable
NCT03624569	Unknown status	Cardiovascular Diseases\|Endotoxemia\|Endothelial Dysfunction\|Postprandial Hyperglycemia\|Gut Health	Ohio State University\|Alliance for Potato Research and Education	2018-08-15	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Erythritol functions as a non-nutritive polyol that bypasses standard glycolytic degradation, thereby limiting postprandial glucose spikes and downstream insulin-mediated intracellular signaling. By dampening glycemic fluctuations and regulating intestinal osmotic balance, this metabolic neutrality supports cellular metabolic stability, providing therapeutic relevance in clinical studies evaluating irritable bowel syndrome, postprandial hyperglycemia, and endothelial dysfunction in cardiovascular health.

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>).