Evaluation of a Combination of a Plant Extract and a Probiotic on Glucidic Metabolism in Women With PCOS and High Insulin Levels
NCT ID: NCT04029805
Last Updated: 2020-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
34 participants
INTERVENTIONAL
2019-05-29
2020-08-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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 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
Volunteers will take twice at day for 12 weeks a capsule containing maltodextrin.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion 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
* 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.
18 Years
FEMALE
No
Sponsors
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Biosearch S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Nicolás Mendoza, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Professor of Gynecology at the Faculty of Medicine of the University of Granada
Locations
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Clinica Margen
Granada, Andalusia, Spain
Countries
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Central Contacts
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Other Identifiers
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P044
Identifier Type: -
Identifier Source: org_study_id
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