The aim of the present study is to evaluate the effect of the combination of a plant extract (BSL\_EP044) and Lactobacillus BSL\_PS6 on parameters of the glucidic metabolism, anthropometric parameters, hormonal levels and the menstrual cycle in women with polycystic ovary syndrome and high insulin levels.
Polycystic ovary syndrome (PCOS) is the most prevalent endocrinopathy in women, affecting 4-15% of those who are of childbearing age. It is a complex and heterogeneous disease in which the gynecological disorder coexist with metabolic problems such as insulin resistance. The beneficial effect of the extract plant BSL-EP044 on glycemic metabolism in women with PCOS is widely studied and demonstrated and Lactobacillus BSL\_PS6 appears to exert a synergistic effect by supplementing the effect of BSL-EP044. The hypothesis of our study is that the addition of the probiotic strain Lactobacillus BSL\_PS6 to extract plant BSL-EP044 treatment may improve the beneficial effect of this one on insulin resistance and other metabolic alterations related to PCOS. The main objective of the present study is to evaluate the effect of the combination of a Plant Extract (BSL\_EP044) and Lactobacillus BSL\_PS6 on parameters related to glycemic metabolism in women with polycystic ovary syndrome and high insulin levels.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
34
Each participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life.
Each participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life.
Clinica Margen
Granada, Andalusia, Spain
RECRUITINGPlasma insulin
Levels of plasma insulin
Time frame: 12 weeks
Plasma glucose
Levels of plasma glucose
Time frame: 12 weeks
HOMA
Insulin sensitivity
Time frame: 12 weeks
Total testosterone
Total testosterone
Time frame: 12 weeks
Free testosterone
Free testosterone
Time frame: 12 weeks
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