Efficacy and Safety of Omija (Schisandra chinensis) Extract Mixture on the Improvement of Hyperglycemia: A Randomized, Double-Blind, and Placebo-Controlled Clinical Trial
What this study found
OSM supplementation for 12 weeks improved glycemic control overall, with several glucose and insulin-related markers favoring the active group and no clinically meaningful safety concerns. In the OSM arm, fasting glucose, fructosamine, and insulin resistance markers improved over time; fructosamine showed a between-group difference versus placebo (p = 0.033), insulin AUC also differed between groups (p = 0.012; adjusted p = 0.011), and AMPK differed between groups (p = 0.047). HbA1c improved within the OSM arm (p = 0.002) but did not differ significantly from placebo (between-group p =…
- Study & population
- Randomized, double-blind, placebo-controlled trial in adults with hyperglycemia, defined by screening fasting plasma glucose 100 to <140 mg/dL, aged 19 to 70 years, and without diagnosed diabetes.
- Intervention
- The active intervention was an oral Omija extract mixture (OSM) at 500 mg/day for 12 weeks.
- Key limitation
- The active arm had a modest analyzed sample size of 34 and the intervention lasted only 12 weeks.
View source
Open PDFOriginal 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.