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

Insulin Resistance Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04029805
• Other study ID #: P044
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 29, 2019
• Est. completion date: August 30, 2020

Study information

• Verified date: July 2019
• Source: Biosearch S.A.
• Contact: Juristo Fonollá, PhD
• Phone: +34958240288
• Email: Juristo.FonollaJoya[@]biosearchlife.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: August 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Insulin Resistance
• Polycystic Ovarian Syndrome
• Polycystic Ovary Syndrome
• Syndrome

Intervention

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
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.

Locations

Country	Name	City	State
Spain	Clinica Margen	Granada	Andalucia

Sponsors (1)

Lead Sponsor	Collaborator
Biosearch S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight	Weight variation throughout the study	12 weeks
Other	BMI	Body mass index	12 weeks
Other	Blood pressure	Systolic and diastolic pressure during the study	12 weeks
Other	Ovarian cycle	Duration of the ovarian cycle	12 weeks
Primary	Plasma insulin	Levels of plasma insulin	12 weeks
Primary	Plasma glucose	Levels of plasma glucose	12 weeks
Primary	HOMA	Insulin sensitivity	12 weeks
Secondary	Total testosterone	Total testosterone	12 weeks
Secondary	Free testosterone	Free testosterone	12 weeks