Efficacy and Safety of Omija (Schisandra chinensis) Extract Mixture on the Improvement of Hyperglycemia: A Randomized, Double-Blind, and Placebo-Controlled Clinical Trial

Abstract

A previous animal study demonstrated that the administration of Omija extract and soybean mixture (OSM) improved glycemic control in the type 2 diabetes model. In this study, we conducted a 12-week, randomized, double-blinded, and placebo-controlled clinical trial to determine the effects of OSM in humans with hyperglycemia. Participants with fasting plasma concentrations of 100–140 mg/dL were enrolled (n = 80) and administered either OSM or placebo products for 12 weeks. The outcomes included measurements of efficacy (fasting plasma glucose (FPG), postprandial glucose (PPG), fasting plasma insulin (FPI), postprandial insulin (PPI), hemoglobin A1c (HbA1c), C-peptide, fructosamine, and lipid parameters) and safety at baseline and at 12 weeks. After the intervention, the OSM group showed significantly decreased levels of FPG, PPG (30, 60 min), PPI (60 min), insulin area under the curve (AUC), fructosamine, and low-density-lipoprotein (LDL) cholesterol compared to the placebo group. No clinically significant changes in any safety parameter were observed. Therefore, it is hypothesized that OSM supplementation is an effective and safe functional food supplement for humans with hyperglycemia.

Anti-Neuroinflammatory Effects of Adaptogens: A Mini-Review

“…In the case of E. senticosus , arterial hypertension was recognized as a contradiction for use [ 106 ]. In turn, S. chinensis in a study by Kim [ 107 ] did not induce any serious negative effects. Only painful complaints were recorded; however, no clear association with the extract was observed.…”

Schisandra extract ameliorates arthritis pathogenesis by suppressing the NF‐κB and MAPK signalling pathways

“…We suggest that the preparation of therapeutic agents using not only the Schisandra extract but also natural extracts containing various active compounds may be potentially used to treat OA. Furthermore, some studies have demonstrated the use of S. chinensis extract in clinical trials and applications for various diseases 60,61 . Therefore, further research is needed to confirm its efficacy in treating patients with OA.…”

“…Furthermore, some studies have demonstrated the use of S. chinensis extract in clinical trials and applications for various diseases. 60 , 61 Therefore, further research is needed to confirm its efficacy in treating patients with OA. Hence, we anticipate that through the outcomes of this study and subsequent research endeavours, S. chinensis extract may effectively mitigate the underlying pathogenesis of human OA.…”