Berberine and Polycystic Ovary Syndrome
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Berberine 2 daily oral doses (one before lunch and one dinner) of 550 mg of berberine tablets |
Dietary Supplement: Berberine
2 daily oral doses (one before lunch and one dinner) of 550 mg of berberine tablets
|
Outcome Measures
Primary Outcome Measures
- 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
- Changes on inflammation [Changes from baseline inflammation at 8 weeks]
C-Reactive Protein (mg/dl)
- 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]
Glycemia (mg/dl)
- Changes on Carbohydrate profile [Changes from baseline Carbohydrate profile at 8 weeks]
Insulin (mcU/ml)
- Changes on Hormonal profile [Changes from baseline Hormonal profile at 8 weeks]
Sex Hormone Binding Globulin (nmol/l)
- Changes on Hormonal profile [Changes from baseline Hormonal profile at 8 weeks]
Testosterone (ng/ml)
- Changes on Hormonal profile [Changes from baseline Hormonal profile at 8 weeks]
Free Androgen Index (ratio)
- Changes on safety [Changes from baseline safety at 8 weeks]
Aspartate aminotransferase (IU/l), alanine aminotransferase (IU/l)
- Changes on safety [Changes from baseline safety at 8 weeks]
Total bilirubin (mg/dl)
- 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]
waist circumference (cm), hip circumference (cm)
- Changes on anthropometry [Changes from baseline anthropometry at 8 weeks]
Weight (kg)
- Changes on anthropometry [Changes from baseline anthropometry at 8 weeks]
Body Mass Index (Kg/m2)
- Changes on body composition [Changes from baseline body composition at 8 weeks]
Fat mass (g), lean mass (g), visceral adipose tissue (g)
- Changes on acne assessment [Changes from baseline acne assessment at 8 weeks]
Global Acne Grading System (scale): each type of acne lesion is given a value depending on severity: no lesions = 0, comedones = 1, papules = 2, pustules = 3, and nodules = 4. Each of the location was graded separately on 0-4 scale, with the most severe lesion within that location determining the local score. The severity was then graded according to the global score which is the summation of all local scores. A score of 1-6 was considered mild; 7-18, moderate; 19- 26, severe; and 27-32, very severe. The maximum score was 32
- 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)
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Azienda di Servizi alla Persona | Pavia | Italy | 27100 |
Sponsors and Collaborators
- Azienda di Servizi alla Persona di Pavia
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1206/14122018