Clinical Trials

Multiple clinical trials have evaluated Secoisolariciresinol diglucoside across diverse physiological conditions. These completed Phase 2 studies were conducted by industry and academic sponsors, including Adocia and the University of Saskatchewan in collaboration with the Saskatchewan Health Research Foundation. The research assessed the compound's therapeutic relevance in Type 1 Diabetes Mellitus, as well as the impact of dietary supplementation on oxidative stress, systemic inflammation, dementia-associated cognitive decline, aging, and pain.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04816890 Completed
Type 1 Diabetes Mellitus
Adocia
 2021-03-23 Phase 2
NCT01234506 Completed
Oxidative Stress|Inflammation|Aging|Dementia|Pain
University of Saskatchewan|Saskatchewan Health Research Foundation
 2010-10 Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a bioactive plant lignan, Secoisolariciresinol diglucoside scavenges reactive oxygen species and suppresses pro-inflammatory signaling cascades, thereby preventing oxidative macromolecular damage and cellular stress. This systemic antioxidant and anti-inflammatory activity protects targeted tissues, providing clinical utility in mitigating oxidative stress, systemic inflammation, and metabolic dysfunction associated with Type 1 Diabetes Mellitus, dementia, aging, and chronic pain.

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.