Evaluation of the efficacy and safety of fermented red ginseng product (FRGP) for improving blood sugar and blood cholesterol: 12 week, multicenter, randomized, double-blind, placebo-controlled clinical trial

Abstract Background: Recent experiments have suggested that fermented red ginseng (FRG) could benefit people with dyslipidemia and impaired fasting glucose (IFG). According to many studies, the intake of probiotic bacteria may improve glucose and lipid homeostasis. However, there are no studies on the benefits of fermented red ginseng products (FRGPs), which are a mixture of these products. This finding to be further validated. Methods: A total of 83 people (20~75 years) with elevated blood lipids and fasting glucose levels were enrolled in a 12-week supplementation with FGRP extract-based formulations (n = 41) or a placebo (n = 42). However, 17 people were excluded, and statical analysis was performed on 65 people (FGRP extract-based formulation (n = 30) and placebo (n = 35)). All body mass index (BMI), vital sign and fasting blood test data were collected 3 times at baseline, 6 weeks, and 12weeks. The data obtained were analyzed using SAS software. The adverse effects of FRGP were also recorded. Results: No group differences were found in baseline body weight, body mass index (BMI), total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C) or glucose levels. Compared with placebo, FRGP supplementation resulted in lower TG levels (-27.43± 63.18 mg/dl vs. 8.83± 46.40 mg/dl, P = 0.0099). The frequency of adverse events in the therapy group was not significantly greater than that in the placebo group. Conclusions: Twelve weeks of FRGP supplementation could improve lipid metabolism in adults with dyslipidemia and IFG. Trial registration: KCT0002583; September 26, 2017.