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

Sponsor

Biosearch S.A. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT04029805

Collaborator

(none)

Enrollment

Location

Arms

15.1

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovarian Syndrome Insulin Resistance	Combination Product: Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6 Combination Product: Placebo	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 29, 2019

Actual Primary Completion Date :

May 30, 2020

Anticipated Study Completion Date :

Aug 30, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Plasma insulin [12 weeks]
Levels of plasma insulin
Plasma glucose [12 weeks]
Levels of plasma glucose
HOMA [12 weeks]
Insulin sensitivity

Secondary Outcome Measures

Total testosterone [12 weeks]
Total testosterone
Free testosterone [12 weeks]
Free testosterone

Other Outcome Measures

Weight [12 weeks]
Weight variation throughout the study
BMI [12 weeks]
Body mass index
Blood pressure [12 weeks]
Systolic and diastolic pressure during the study
Ovarian cycle [12 weeks]
Duration of the ovarian cycle

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.