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

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

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.

Study Overview

• Status: Unknown
• Conditions: Insulin Resistance; Polycystic Ovarian Syndrome
• Intervention / Treatment: Combination product: Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6; Combination product: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Spain
  • Andalucia
    • Granada, Andalucia, Spain, 18006
      • Recruiting
      • Clinica Margen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination of a Plant Extract and a Probiotic; 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; 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.
Placebo Comparator: Placebo; Volunteers will take twice at day for 12 weeks a capsule containing maltodextrin.	Combination product: Placebo; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Weight variation throughout the study	12 weeks
BMI	Body mass index	12 weeks
Blood pressure	Systolic and diastolic pressure during the study	12 weeks
Ovarian cycle	Duration of the ovarian cycle	12 weeks

Collaborators and Investigators

• Sponsor: Biosearch S.A.
• Investigators: Principal Investigator: Nicolás Mendoza, MD, PhD, Professor of Gynecology at the Faculty of Medicine of the University of Granada

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2019
• Primary Completion (Actual): May 30, 2020
• Study Completion (Anticipated): August 30, 2020

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 23, 2019

Study Record Updates

• Last Update Posted (Actual): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Insulin resistance; Probiotics; Polycystic ovarian syndrome; Extract plant
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Hyperinsulinism; Polycystic Ovary Syndrome; Syndrome; Insulin Resistance
• Other Study ID Numbers: P044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No