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

Biosearch Life

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Insulin Resistance; Polycystic Ovarian Syndrome

Treatments: Combination Product: Placebo; Combination Product: Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6

Study type: Interventional

Funder types: Industry

Identifiers

NCT04029805

P044

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 2 patient groups, including a placebo group

Combination of a Plant Extract and a Probiotic

Experimental group

Description:

Volunteers will take twice at day for 12 weeks a capsule containing the combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6

Treatment:

Combination Product: Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6

Placebo

Placebo Comparator group

Description:

Volunteers will take twice at day for 12 weeks a capsule containing maltodextrin.

Treatment:

Combination Product: Placebo