- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04029805
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
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Juristo Fonollá, PhD
- Phone Number: +34958240288
- Email: Juristo.FonollaJoya@biosearchlife.com
Study Locations
-
-
Andalucia
-
Granada, Andalucia, Spain, 18006
- Recruiting
- Clinica Margen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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.
|
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
Time Frame: 12 weeks
|
Levels of plasma insulin
|
12 weeks
|
Plasma glucose
Time Frame: 12 weeks
|
Levels of plasma glucose
|
12 weeks
|
HOMA
Time Frame: 12 weeks
|
Insulin sensitivity
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total testosterone
Time Frame: 12 weeks
|
Total testosterone
|
12 weeks
|
Free testosterone
Time Frame: 12 weeks
|
Free testosterone
|
12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight
Time Frame: 12 weeks
|
Weight variation throughout the study
|
12 weeks
|
BMI
Time Frame: 12 weeks
|
Body mass index
|
12 weeks
|
Blood pressure
Time Frame: 12 weeks
|
Systolic and diastolic pressure during the study
|
12 weeks
|
Ovarian cycle
Time Frame: 12 weeks
|
Duration of the ovarian cycle
|
12 weeks
|
Collaborators and Investigators
Sponsor
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)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P044
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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