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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination of a Plant Extract and a Probiotic | Experimental | Volunteers will take twice at day for 12 weeks a capsule containing the combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6 |
|
| Placebo | Placebo Comparator | Volunteers will take twice at day for 12 weeks a capsule containing maltodextrin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6 | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma insulin | Levels of plasma insulin | 12 weeks |
| Plasma glucose | Levels of plasma glucose | 12 weeks |
| HOMA | Insulin sensitivity | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total testosterone | Total testosterone | 12 weeks |
| Free testosterone | Free testosterone | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Weight variation throughout the study | 12 weeks |
| BMI | Body mass index | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juristo Fonollá, PhD | Contact | +34958240288 | Juristo.FonollaJoya@biosearchlife.com |
| Name | Affiliation | Role |
|---|---|---|
| Nicolás Mendoza, MD, PhD | Professor of Gynecology at the Faculty of Medicine of the University of Granada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Margen | Recruiting | Granada | Andalusia | 18006 | Spain |
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| Placebo | Combination Product | 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. |
|
| Blood pressure | Systolic and diastolic pressure during the study | 12 weeks |
| Ovarian cycle | Duration of the ovarian cycle | 12 weeks |
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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