Leaky Gut and Post-Prandial, Redox and Inflammatory Markers in HRTTreated Menopausal Females: Benefits by a Pharma-Grade Fermented Papaya Preparation (FPP-ORI)

The aim of the present study was to test an evidence-based functional food (FPP-ORI, Osato Research Institute, Gifu, Japan) on redox and immune system modulatory efficiency together with gut permeability in HRT-treated postmenopause women. The study population consisted of 74 postmenopausal women who were on hormone replacement therapy (HRT) divided in two groups, matched as for age, duration of menopause diagnosis, BMI, dietary intake and physical activity and supplemented as follows: Group A unsupplemented HRT-treated women and group B HRT-treated women supplemented with FPP 4.5 g 2 times a day. Treatments were maintained for 6 months. A further Group C consisted of 25 untreated menopausal women who served as control. A high-fat test meal was given to both groups as breakfast each observation day (entry, at 3rd and 6th months) afterwards. At these timing blood samples were taken for the following tests: erythrocytes redox parameters, oxidized low-density lipoproteins/ β2-glycoprotein I (oxLDL/b2GPI), interleukin 6 (IL6) and lypopolysaccharide (LPS). As compared to group C, group A did not any significant change of MDA and redox parameters concentration. However, in subnot jects with BMI<24, HRT treatment was associated to a significant beneficial variation of MDA but of the other redox parameters (GPx, SOD1 and CAT). FPP supplementation yielded a significant improvement of all redox parameters at 6 months (p<0.01) irrespective of the BMI. Plasma oxLDL/b2GPI in group A was abnormally high (2 h and 4 h values vs. baseline, p<0.05). Supplementation with FPP showed a significant normalization of this parameter (p<0.05 vs. group A after challenge meal). LPS and IL-6 showed a significant time-course increase in group A. However,this phenomena were improved in group B (p<0.01). Taken overall the above evidence-based FPP nutraceutical intervention may provide a valid opportunity within a wider health-promoting and disease-preventing, namely neuro-protective, strategy in menopausal women.