NCT04029805

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

July 10, 2020

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

July 22, 2019

Last Update Submit

July 9, 2020

Conditions

Polycystic Ovarian SyndromeInsulin Resistance

Keywords

Polycystic ovarian syndromeExtract plantProbioticsInsulin resistance

Outcome Measures

Primary Outcomes (3)

  • Plasma insulin

    Levels of plasma insulin

    12 weeks

  • Plasma glucose

    Levels of plasma glucose

    12 weeks

  • HOMA

    Insulin sensitivity

    12 weeks

Secondary Outcomes (2)

  • Total testosterone

    12 weeks

  • Free testosterone

    12 weeks

Other Outcomes (4)

  • Weight

    12 weeks

  • BMI

    12 weeks

  • Blood pressure

    12 weeks

  • +1 more other outcomes

Study Arms (2)

Combination of a Plant Extract and a Probiotic

EXPERIMENTAL

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 Product: Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6

Placebo

PLACEBO COMPARATOR

Volunteers will take twice at day for 12 weeks a capsule containing maltodextrin.

Combination Product: Placebo

Interventions

Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6COMBINATION_PRODUCT

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 of a Plant Extract and a Probiotic
PlaceboCOMBINATION_PRODUCT

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Margen

Granada, Andalusia, 18006, Spain

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary SyndromeInsulin Resistance

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Nicolás Mendoza, MD, PhD

    Professor of Gynecology at the Faculty of Medicine of the University of Granada

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juristo Fonollá, PhD

CONTACT

+34958240288Juristo.FonollaJoya@biosearchlife.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2019

First Posted

July 23, 2019

Study Start

May 29, 2019

Primary Completion

May 30, 2020

Study Completion

August 30, 2020

Last Updated

July 10, 2020

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)