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

Primary Purpose

Polycystic Ovarian Syndrome, Insulin Resistance

Status
Unknown status
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6
Placebo
Sponsored by
Biosearch S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovarian Syndrome focused on measuring Polycystic ovarian syndrome, Extract plant, Probiotics, Insulin resistance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Clinica MargenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Combination of a Plant Extract and a Probiotic

Placebo

Arm 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

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

Outcomes

Primary Outcome Measures

Plasma insulin
Levels of plasma insulin
Plasma glucose
Levels of plasma glucose
HOMA
Insulin sensitivity

Secondary Outcome Measures

Total testosterone
Total testosterone
Free testosterone
Free testosterone

Full Information

First Posted
July 22, 2019
Last Updated
July 9, 2020
Sponsor
Biosearch S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT04029805
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 29, 2019 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
August 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosearch S.A.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovarian Syndrome, Insulin Resistance
Keywords
Polycystic ovarian syndrome, Extract plant, Probiotics, Insulin resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combination of a Plant Extract and a Probiotic
Arm Type
Experimental
Arm 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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Volunteers will take twice at day for 12 weeks a capsule containing maltodextrin.
Intervention Type
Combination Product
Intervention Name(s)
Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Plasma insulin
Description
Levels of plasma insulin
Time Frame
12 weeks
Title
Plasma glucose
Description
Levels of plasma glucose
Time Frame
12 weeks
Title
HOMA
Description
Insulin sensitivity
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Total testosterone
Description
Total testosterone
Time Frame
12 weeks
Title
Free testosterone
Description
Free testosterone
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Weight
Description
Weight variation throughout the study
Time Frame
12 weeks
Title
BMI
Description
Body mass index
Time Frame
12 weeks
Title
Blood pressure
Description
Systolic and diastolic pressure during the study
Time Frame
12 weeks
Title
Ovarian cycle
Description
Duration of the ovarian cycle
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juristo Fonollá, PhD
Phone
+34958240288
Email
Juristo.FonollaJoya@biosearchlife.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolás Mendoza, MD, PhD
Organizational Affiliation
Professor of Gynecology at the Faculty of Medicine of the University of Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Margen
City
Granada
State/Province
Andalucia
ZIP/Postal Code
18006
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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