Klinische Pharmakologie und Biopharmazeutik

Abstrakt

A Randomized Study Assessing the Effect of Nattokinase-Meriva Formula on Low Grade Inflammation and Blood Viscosity in Adults with Increased Visceral Adiposity

Rasulova S, Jude Tan S, Zerbinati N, Rastmanesh R, Pathak S, Celep G, Banerjee A, Kumar N

Background: Chronic systemic inflammation in obesity spurs from local immune responses generated from visceral adipose body compartment and this entails a wide range of inflammation-mediating cytokines and adipometrics plasticity. On the other hand, while obesity is a leading risk factor for type 2 diabetes, its prevalence is significantly in the elderly. As a matter of fact, it has been shown that the age-associated increase in adipose tissue inflammation represents a different entity from what observed in obesity. In both contexts, a silent low-grade inflammation of adipose tissue (AT), mainly visceral AT (VAT) in which M1 are the main contributors, is a common pathophysiological feature behind insulin resistance and type 2 diabetes (T2D).

Aim of the study: The aim of this study was to characterize the profile of a broad range of pro-inflammatory cytokines, their related gene expression and blood viscosity in individuals with general mild-moderate overweight and in non-obese subjects with increased VAT.

Study design: This was a cross-sectional investigational research including 66 mildly overweight patients (body mass index (BMI) ≤ 29) and also 31 non-overweight subjects (BMI ≤ 22) with impending metabolic syndrome, classified as normal-weight obese (NWO). Subjects were supplemented with 1cp two times a day of J2622/G (Modulase, Named ltd, Italy), a mixture of nattokinase, high-absorption curcumin (Meriva), Bromelin, papain, and mirrha.

Results: As compared to healthy control, overweight status was associated with significantly elevated levels of IL- 6, TNF-α, IL-1β, MCP-1, IL-4, IL13, IL-8 and hsCRP (p<0.05). Treatment with J2622/G enabled a significant decreased of all the above inflammatory markers (p<0.01) whereas it did not affect the values of those markers which were within normal limits at baseline. Cytokines significantly correlated with adipometrics, irrespective of the mildly overweight or NWO subgroups. Gene expressions related to those abnormal cytokines were found to be significantly up regulated (p<0.05) and were reverted to healthy control gene expression levels at the end of the treatment period (p<0.05). There was no correlation between blood viscosity and antrometrics, nor the former were different from healthy control. However, the treatment with J2622/G already after 1 months treatment yielded a statistically significant decrease of blood viscosity (p<0.05). Adiponectin was found to be decreased only in the 25-29 BMI cohort and this was increased at the end of nutraceutical treatment (p<0.05).

Conclusion: We confirmed that either mild over-weight and NWO subjects harbor a relentless low-grade inflammation which may pave the way to silent progression of cardiovascular and metabolic diseases. A nattokinasemeriva formulation proved to yield a therapeutic and likely preventative efficacy for its robust anti-inflammatory and microcirculatory properties.