Efficacy and Safety of Omija (Schisandra chinensis) Extract Mixture on the Improvement of Hyperglycemia: A Randomized,Double-Blind,and Placebo-Controlled Clinical Trial |
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Authors: | Da-Som Kim Hyang-Im Baek Ki-Chan Ha Youn-Soo Cha Soo-Jung Park |
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Affiliation: | 1.Healthcare Claims & Management Incorporation, Jeonju 54858, Korea; (D.-S.K.); (H.-I.B.); (K.-C.H.);2.Departments of Food Science & Human Nutrition, Jeonbuk National University, Jeonju 54896, Korea;3.Department of Food Science & Nutrition, Woosuk University, Wanju 55338, Korea;4.Korea Food Research Institute, 245, Wanju 55365, Korea;5.Department of Sasang Constitutional Medicine, College of Korean Medicine, Woosuk University, Jeonju 55338, Korea |
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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. |
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Keywords: | Omija Schisandra chinensis soybean Omija extract mixture glycemic control type 2 diabetes clinical trial |
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