Berberine and Polycystic Ovary Syndrome

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome; Berberine
• Interventions: Dietary Supplement: Berberine

• Registration Number: NCT04932070
• Lead Sponsor: Azienda di Servizi alla Persona di Pavia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-05
• Primary Completion: 2020-10-06
• Study Completion: 2021-01-26
• Status Verified: 2021-06
• Study First Submitted: 2021-06-14
• Study First Submitted QC: 2021-06-17
• Last Update Submitted: 2021-06-17
• Study First Posted: 2021-06-18
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Changes on insulin resistance	Changes from baseline insulin resistance at 8 weeks	Homeostasis Model Assessment (pt), for evaluate insulin resistance if \> 2.4

Secondary Outcome Measures

Name	Time	Method
Changes on inflammation	Changes from baseline inflammation at 8 weeks	Tumor Necrosis Factor alpha (pg/ml)
Changes on lipid profile	Changes from baseline lipid profile at 8 weeks	Total Cholesterol (mg/dl), High Density Lipoprotein Cholesterol (mg/dl), Low Density Lipoprotein Cholesterol (mg/dl), Very Low Density Lipoprotein (mg/dl),Triglycerides (mg/dl)
Changes on Carbohydrate profile	Changes from baseline Carbohydrate profile at 8 weeks	Insulin (mcU/ml)
Changes on safety	Changes from baseline safety at 8 weeks	Gamma Glutamyl Transferase (U/I), Creatine Phosphokinase (U/I)
Changes on anthropometry	Changes from baseline anthropometry at 8 weeks	Body Mass Index (Kg/m2)
Changes on acne assessment	Changes from baseline acne assessment at 8 weeks	Cardiff Acne Disability Index (scale): the Cardiff Acne Disability Index consists of five questions with a Likert scale, four response categories (0-3). The five questions relate to feeling of aggression, frustration, interference with social life, avoidance of public changing facilities and appearance of the skin-all over the last month-and an indication of how bad the acne was now. The CADI score was calculated by summing the score of each question resulting in a possible maximum of 15 and minimum of 0. CADI scores were graded as low (0-4), medium (5-9), and high (10-15)
Changes on Hormonal profile	Changes from baseline Hormonal profile at 8 weeks	Free Androgen Index (ratio)
Changes on body composition	Changes from baseline body composition at 8 weeks	Fat mass (g), lean mass (g), visceral adipose tissue (g)

Trial Locations

Locations (1)

Azienda di Servizi alla Persona; 🇮🇹 Pavia, Italy