Efficacy and Safety of Aronia, Red Ginseng, Shiitake Mushroom, and Nattokinase Mixture on Insulin Resistance in Prediabetic Adults: A Randomized, Double-Blinded, Placebo-Controlled Trial

Abstract

We determined whether oral consumption of Aronia, red ginseng, shiitake mushroom, and nattokinase mixture (3.4: 4.1: 2.4: 0.1 w/w; AGM) improved glucose metabolism and insulin resistance in prediabetic adults in a 12-week randomized, double-blinded clinical trial. Participants with fasting serum glucose concentrations of 100–140 mg/dL were recruited and randomly assigned to an AGM or placebo group. Participants of the AGM group (n = 40) were given an AGM granule containing 4 g of freeze-dried Aronia, red ginseng, shiitake mushroom, and nattokinase (3.4: 4.1: 2.4: 0.1 w/w) twice daily for 12 weeks, and the placebo group participants (n = 40) were provided with corn starch granules identical in appearance, weight, and flavor for 12 weeks. Serum glucose and insulin concentrations were measured during oral-glucose tolerance tests (OGTT) after administering 75 g of glucose in a fasted state. HOMA-IR, liver damage, and inflammation indices were determined, and safety parameters and adverse reactions were assessed. As determined by OGTT, serum glucose concentrations were not significantly different between the AGM and placebo groups after the intervention. However, changes in serum insulin concentrations in the fasted state and Homeostatic model assessment-insulin resistance (HOMA-IR) index after the intervention were significantly lower in the AGM group than in the placebo group (−3.07 ± 7.06 vs. 0.05 ± 6.12, p = 0.043 for serum insulin; −0.85 ± 2.14 vs. 0.07 ± 1.92, p = 0.049 for HOMA-IR). Serum adiponectin concentrations were reduced by intervention in the placebo group but not in the AGM group. Changes in liver damage indexes, including serum activities of the γ-glutamyl transferase, alanine aminotransferase, and aspartate aminotransferase, were lower in the AGM group and significantly reduced in the AGM group more than in the placebo group (p < 0.05). Changes in serum high sensitive-C-reactive protein concentrations in AGM and placebo groups were significantly different (−0.12 ± 0.81 vs. 0.51 ± 1.95, p = 0.06). In conclusion, AGM possibly improves insulin sensitivity and β-cell function and reduces liver damage and inflammation in prediabetic adults.

Effects of Aronia melanocarpa on Cardiometabolic Diseases: A Systematic Review of Quasi-Design Studies and Randomized Controlled Trials

“…Thus, Aronia may be beneficial in persons with more severe or poorly controlled T2D, but no conclusions can be drawn due to the low number of studies. In addition, one RCT examining supplementation with a mixture of Aronia, red ginseng, shitake mushroom, and nattokinases in 40 prediabetic individuals found that this mixture compared to placebo had no impact on glucose levels during an oral glucose tolerance test but improved fasting insulin and HOMA-IR index [ 107 ]. However, this study does not clarify the impact of Aronia per se, and therefore, is not included in the analysis.…”

Microbial nattokinase: from synthesis to potential application

“…It also improves glucose metabolism in insulin-deficient type 2 diabetic rats by enhancing insulin secretion and reducing insulin resistance. 27,126 Li X used genetic engineering to clone long-acting glucagon-like peptide-1 (5 × GLP-1) and NK into E. coli by SOE PCR to obtain a fusion peptide with significant antithrombotic properties, resulting in fasting blood glucose levels similar to normal levels in experimental mice (Fig. 4).…”

“…Researchers have studied crude extracts of NK and have shown that NK can effectively prevent or treat blood clots through direct or indirect routes and intervene in diseases such as hypertension, hyperglycemia, and liver cancer. [24][25][26][27][28] In addition, NK-producing strains not only produce NK when acting on different substrates but also give different properties to fermented foods depending on the fermentation substrate, such as an improvement of antioxidant activity and absorbability, and the production of polyphenolic compounds. 22,29,30 Therefore, safe strains with the ability to produce NK can also potentially develop functional foods.…”

The Efficacy of Ginseng (Panax) on Human Prediabetes and Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis

“…Of those, 1236 RCTs were not relevant to the subject, leaving 202 records eligible for full-text review. Furthermore, after excluding 6 studies examining the impact of ginseng in combination with other ingredients due to the impossibility of determining the independent effect of ginseng [43][44][45][46][47][48], 3 eligible studies which reported in a language other than English [49][50][51], 1 study with multiple-crossover, acute dose escalation design [52], and 172 records which did not provide sufficient data and/or did not fulfill the inclusion criteria, 20 RCTs with 24 effect sizes met the inclusion criteria for qualitative synthesis.…”