Berberine, Polycystic Ovary Syndrome
Conditions
Keywords
berberine, Polycystic Ovary Syndrome
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.
Interventions
DIETARY_SUPPLEMENTBerberine
2 daily oral doses (one before lunch and one dinner) of 550 mg of berberine tablets
Sponsors
Azienda di Servizi alla Persona di Pavia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes on insulin resistance | Changes from baseline insulin resistance at 8 weeks | Homeostasis Model Assessment (pt), for evaluate insulin resistance if \> 2.4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes on anthropometry | Changes from baseline anthropometry at 8 weeks | waist circumference (cm), hip circumference (cm) |
| Changes on inflammation | Changes from baseline inflammation at 8 weeks | C-Reactive Protein (mg/dl) |
| 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 body composition | Changes from baseline body composition at 8 weeks | Fat mass (g), lean mass (g), visceral adipose tissue (g) |
| Changes on Hormonal profile | Changes from baseline Hormonal profile at 8 weeks | Sex Hormone Binding Globulin (nmol/l) |
| Changes on safety | Changes from baseline safety at 8 weeks | Aspartate aminotransferase (IU/l), alanine aminotransferase (IU/l) |
| 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 Carbohydrate profile | Changes from baseline Carbohydrate profile at 8 weeks | Glycemia (mg/dl) |
Countries
Italy
Outcome results
None listed