Clinical Pharmacology & Biopharmaceutics
Open Access

Research Article

A 2-year Double-Blind RCT Follow-up Study with Fermented Papaya Preparation (FPP) Modulating Key Markers in Middle-Age Subjects with Clustered Neurodegenerative Disease-Risk Factors

¹ReGenera Research Group for Aging Intervention, San Babila Clinic, Milano, Italy

²WHO-Center for Traditional Medicine and Biotechnology, University of Milano, Italy

³Department of Internal Medicine, University of Catania, Catania, Italy

⁴Center for Diabetes, Obesity and Metabolism, Wake Forest Medical Center, Biotech Place, Winston-Salem, USA

⁵Evolutionary Cytogerontology Sector, School of Biology, Moscow State University, Moscow, Russia

⁶Osato Research Institute and Labs, Gifu, Japan

*Corresponding Author:

Prof. Francesco Marotta
ReGenera Research Group for Aging Intervention
San Babila Clinic, Corso Matteotti 1/A
20121 Milano, Italy
Tel: +39-024077243
E-mail: fmarchimede@libero.it

Received date: April 28, 2017; Accepted date: May 16, 2017; Published date: May 18, 2017

Citation: Marotta F, Marcellino M, Solimene U, Cuffari B, Yadav H, et al. (2017) A 2-year Double-Blind RCT Follow-up Study with Fermented Papaya Preparation (FPP) Modulating Key Markers in Middle-Age Subjects with Clustered Neurodegenerative Disease-Risk Factors. Clin Pharmacol Biopharm 6:170. doi: 10.4172/2167-065X.1000170

Copyright: © 2017 Marotta 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.

In recent years a number of studies have reported the significant relationship between metabolic syndrome and neurodegenerative disease. There is accumulating evidence that the interplay of combined genetic and environmental risk factors (from diet to life style to pollutants) to intrinsic age-related oxi-inflammatory changes may be advocated for to explain the pandemic of neurodegenerative diseases. In recent years a specific Fermented Papaya Preparation (FPP) has been shown to significantly affect a number of redox signalling abnormalities in a variety of chronic diseases and as well in aging mechanisms either on experimental and on clinical ground. The aim of the present study was to evaluate FPP use in impending metabolic disease patients with potentially neurodegenerative disease clustered risk factors. The study population consisted of 90 patients aged 45-65 years old, with impending metabolic syndrome and previously selected as to be ApoE4 genotype negative. By applying a RCT, double-blind method, one group received FPP 4.5 g twice a day (the most common dosage utilized in prior clinical studies) while the other received an oral antioxidant cocktail (trans-resveratrol, selenium, vitamin E, vitamin C). Then, after 21 month treatment period, a selected heavy metal chelator was added at the dosage of 3 g/nocte for the final 3 months study treatment. The parameters tested were: routine tests oxidized LDL-cholesterol, anti-oxidised LDL, Cyclophilin-A (CyPA), plasminogen activator inhibitor-1 and CyPA gene expression. From this study it would appear that FPP, unlike the control antioxidant, significantly decreased oxidized-LDL and near normalizing the anti- Ox-LDL/Ox-LDL ratio (p<0.001) although unaffecting the lipid profile per sè. Moreover, only FPP decreased cyclophilin-A plasma level and plasminogen activator-inhibitor (p<0.01) together with downregulating cyclophilin-A gene expression (p<0.01). Insulin resistance was only mildly improved. Heavy metals gut clearance proved to be effectively enhanced by the chelator (p<0.01) and this was not affected by any of the nutraceuticals, nor it added any further benefit to the biological action of FPP.

Keywords