NCT04932070

Brief Summary

Polycystic Ovary Syndrome (PCOS) is the most frequent endocrine disease in female reproductive-age. Recently, increasing evidence has shown that natural plant-based products may play a role in PCOS management. Previous study in PCOS preclinical model and in humans demonstrated that berberine is an effective insulin sensitizer and improves homeostasis of metabolic, inflammatory and hormonal disorders. However, to date there is no clinical study that considers globally all the activities carried out by berberine in PCOS clinical features. Given this background, aim of this study was to evaluate in normal-overweight PCOS women with normal menses the berberine effectiveness on: insulin resistance by Homeostasis Model Assessment (HOMA); inflammation by C-Reactive Protein (CRP), TNF-alpha; lipid metabolism; sex hormone profile and symptoms correlated to hyperandrogenism, such as acne, by Global Acne Grading System (GAGS) and Cardiff Acne Disability Index (CADI); body composition by dual-energy X-ray absorptiometry. All these parameters were collected at baseline and 60 days after supplementation with a new bioavailable and safe berberine formulation. Finally, adverse effects were assessed by liver and kidney functions. To evaluate statistically significant pre- post-supplementation changes, fitted a linear mixed model for each investigated endpoint was performed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

1 month

First QC Date

June 14, 2021

Last Update Submit

June 17, 2021

Conditions

Polycystic Ovary SyndromeBerberine

Keywords

berberinePolycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Changes on insulin resistance

    Homeostasis Model Assessment (pt), for evaluate insulin resistance if \> 2.4

    Changes from baseline insulin resistance at 8 weeks

Secondary Outcomes (17)

  • Changes on inflammation

    Changes from baseline inflammation at 8 weeks

  • Changes on inflammation

    Changes from baseline inflammation at 8 weeks

  • Changes on lipid profile

    Changes from baseline lipid profile at 8 weeks

  • Changes on Carbohydrate profile

    Changes from baseline Carbohydrate profile at 8 weeks

  • Changes on Carbohydrate profile

    Changes from baseline Carbohydrate profile at 8 weeks

  • +12 more secondary outcomes

Study Arms (1)

Berberine

EXPERIMENTAL

2 daily oral doses (one before lunch and one dinner) of 550 mg of berberine tablets

Dietary Supplement: Berberine

Interventions

BerberineDIETARY_SUPPLEMENT

2 daily oral doses (one before lunch and one dinner) of 550 mg of berberine tablets

Berberine

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • normal and overweight women (Body Mass Index (BMI) 25-30 kg/m2)
  • newly detected Polycystic Ovary Syndrome

You may not qualify if:

  • any concomitant medication
  • presence of liver, renal and thyroid disease
  • smoking
  • drinking more than two standard alcoholic beverages/day (20 g of alcohol/day)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda di Servizi alla Persona

Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Berberine

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Berberine AlkaloidsBenzylisoquinolinesAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2021

First Posted

June 18, 2021

Study Start

September 5, 2020

Primary Completion

October 6, 2020

Study Completion

January 26, 2021

Last Updated

June 18, 2021

Record last verified: 2021-06

Locations

IT(1)