Effect of an Integrated Nutraceutical Formula on Key Inflammatory Regulators in Subjects with Metabolic Syndrome Features: A Randomized, Double-Blind Study

Abstract

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.