Clinical trial NCT04029805: Evaluation of a Combination of a Plant Extract and a Probiotic on Glucidic Metabolism in Women With PCOS and High Insulin Levels
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Polycystic Ovarian Syndrome
Insulin Resistance
Keywords: Polycystic ovarian syndrome
Extract plant
Probiotics
Insulin resistance
Lead sponsor: Biosearch S.A.
Sponsor class: INDUSTRY
First posted: 2019-07-23
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Plasma insulin
timeFrame: 12 weeks
measure: Plasma glucose
timeFrame: 12 weeks
measure: HOMA
timeFrame: 12 weeks
Secondary outcomes:
measure: Total testosterone
timeFrame: 12 weeks
measure: Free testosterone
timeFrame: 12 weeks
Other outcomes:
measure: Weight
timeFrame: 12 weeks
measure: BMI
timeFrame: 12 weeks
measure: Blood pressure
timeFrame: 12 weeks
measure: Ovarian cycle
timeFrame: 12 weeks
Locations:
city: Granada
country: Spain
facility: Clinica Margen
state: Andalucia
Study officials:
affiliation: Professor of Gynecology at the Faculty of Medicine of the University of Granada
name: Nicolás Mendoza, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: