Clinical trial · Interventional
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
NCT04029805CI-TRIAL-00045904unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Insulin Resistance | — | UNRESOLVED | — |
| Polycystic Ovarian Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6 | Combination Product | — | UNRESOLVED |
| Placebo | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Combination of a Plant Extract and a Probiotic
- description
- Volunteers will take twice at day for 12 weeks a capsule containing the combination of a plant extract (BSL\_EP044) and Lactobacillus BSL\_PS6
- interventionNames
- Combination Product: Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Volunteers will take twice at day for 12 weeks a capsule containing maltodextrin.
- interventionNames
- Combination Product: Placebo
Primary outcomes (3)
- measure
- Plasma insulin
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.