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

Phase 1

• Conditions: Polycystic Ovarian Syndrome; Insulin Resistance
• Interventions: Combination Product: Placebo; Combination Product: Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6

• Registration Number: NCT04029805
• Lead Sponsor: Biosearch S.A.

Brief 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.

Study Timeline

• Study Start: 2019-05-29
• Status Verified: 2019-07
• Study First Submitted: 2019-07-22
• Study First Submitted QC: 2019-07-22
• Study First Posted: 2019-07-23
• Primary Completion: 2020-05-30
• Last Update Submitted: 2020-07-09
• Last Update Posted: 2020-07-10
• Study Completion: 2020-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Volunteers will take twice at day for 12 weeks a capsule containing maltodextrin.
Combination of a Plant Extract and a Probiotic	Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6	Volunteers will take twice at day for 12 weeks a capsule containing the combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6

Primary Outcome Measures

Name	Time	Method
Plasma insulin	12 weeks	Levels of plasma insulin
Plasma glucose	12 weeks	Levels of plasma glucose
HOMA	12 weeks	Insulin sensitivity

Secondary Outcome Measures

Name	Time	Method
Free testosterone	12 weeks	Free testosterone
Total testosterone	12 weeks	Total testosterone

Trial Locations

Locations (1)

Clinica Margen; 🇪🇸 Granada, Andalucia, Spain