NCT04029805

Evaluation of a Combination of a Plant Extract and a Probiotic on Glucidic Metabolism in Women With PCOS and High Insulin Levels

Evaluation of the Effect of a Combination of a Plant Extract (BSL_EP044) and Lactobacillus BSL_PS6 on Glucidic Metabolism in Women Suffering From Polycystic Ovary Syndrome and High Insulin Levels

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Biosearch S.A. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Polycystic Ovarian Syndrome
• Insulin Resistance

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6	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.
COMBINATION_PRODUCT	Placebo	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.

Timeline

• Start date: 2019-05-29
• Primary completion: 2020-05-30
• Completion: 2020-08-30
• First posted: 2019-07-23
• Last updated: 2020-07-10

Locations

1 site across 1 country: Spain