Effect of an Integrated Nutraceutical Formula on Key Inflammatory Regulators in Subjects with Metabolic Syndrome Features: A Randomized, Double-Blind StudyFang He1, Nikhil Kumar2, Francesco Marotta3*, Birbal Singh4, Alexander N Khokhlov5, Manoj Kumar6, Angelo Italia7, Aldo Lorenzetti3, Makoto Kantah3 and Roberto Catanzaro7
- *Corresponding Author:
- Francesco Marotta
San Babila Clinic, ReGenera Research Group for Aging-Intervention
Corso Matteotti, 1/A, 20121 Milano, Italy
E-mail: [email protected]
Received date: February 01, 2017; Accepted date: February 20, 2017; Published date: February 25, 2017
Citation: He F, Kumar N, Marotta F, Singh B, Khokhlov AN, et al. (2017) Effect of an Integrated Nutraceutical Formula on Key Inflammatory Regulators in Subjects with Metabolic Syndrome Features: A Randomized, Double-Blind Study. Clin Pharmacol Biopharm 6:167. doi: 10.4172/2167-065X.1000167
Copyright: © 2017 He F, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
About one fourth of all American adults and a bit less than one sixth of Europeans are reported to be affected by metabolic syndrome. Aging seem associated to a consistent increase of this phenomenon which is now clear to be associated with a low-grade pro-inflammatory cascade. Dyslipidemia is a characteristic factor involved in this multifaceted metabolic setting and this provides new avenues to non-chemical biopharmaceutical interventions. Eighty-two patients (66 males and 16 females, 38-69 as age range) with metabolic syndrome were selected randomly. Patients meeting inclusion criteria were advised to adhere to a standard balanced diet but no specific dietary calorie-restriction or life-style modifications. Two matched patients groups were assigned either to 1 tab/ dinner of drug A and another group received 1 tab/dinner of drug B, both for 3 months. Physicians and patients were blinded as for the content of the tablets except being aware that one being P3/GB-2016 while the other a looking alike placebo. A third group of 25 healthy, normal-weight subjects without any biochemical abnormalities served as control. The mean HbA1c level showed a trend decrease in group I at 3-month observation but this group showed a significant decrease of total and LDL cholesterol, non-HDL aliquot and triglycerides throughout the study period (p<0.05). Serum concentration of either MIP1α or MIF were significantly higher in dysmetabolic patients as compared to healthy control (p<0.01). Treatment with P3/GB-2016 proved to significantly decrease both parameters at 3-month observation (p<0.01). Whereas circulating levels of MCP-1 appeared showed a wide dispersion of data and appearing to be higher in those subjects with highest (n.s.). Overall, P3/GB-2016 seems to be an effective oral agent in controlling dyslipidemia and key regulatory modulator within the management of metabolic syndrome.