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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Polycystic Ovarian Syndrome, Insulin Resistance

Intervention / Treatment
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* Combination Product: Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6
* Combination Product: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being diagnosed with polycystic ovarian syndrome according to the Rotterdam criteria. HOMA values between 2.5 and 3. Body mass index of less than 35 kg/m2. Accept freely to participate in the study and sign the informed consent document. Exclusion Criteria: Women in treatment with oral antidiabetics. Being pregnant or intending to get pregnant. Be in fertility treatment. To suffer from other diseases that affect the hormonal response or that could interfere with the glucidic metabolism.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination of a Plant Extract and a Probiotic<br>Volunteers will take twice at day for 12 weeks a capsule containing the combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6 | Combination Product: Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Volunteers will take twice at day for 12 weeks a capsule containing maltodextrin. | Combination Product: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total testosterone | Total testosterone | 12 weeks | 
| Free testosterone | Free testosterone | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polycystic ovarian syndrome, Extract plant, Probiotics, Insulin resistance