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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

NCT04029805 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-07-10

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Biosearch S.A.

    lead INDUSTRY

Principal Investigators

  • Nicolás Mendoza, MD, PhD · Professor of Gynecology at the Faculty of Medicine of the University of Granada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-29
Primary Completion
2020-05-30
Completion
2020-08-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04029805 on ClinicalTrials.gov