Polycystic Ovary Syndrome (PCOS) With Concurrent Nonalcoholic Fatty Liver Disease (NAFLD)
Conditions
Brief summary
Background and Objectives: Polycystic ovary syndrome (PCOS) and nonalcoholic fatty liver disease (NAFLD) commonly co-occur and are associated with insulin resistance, chronic inflammation, and metabolic and hormonal imbalances. Standard drug therapies can cause side effects, so safer and more effective alternatives are needed. This study evaluated whether daily curcumin supplementation could improve lipid, metabolic, hormonal, and liver-related parameters in women of reproductive age with both PCOS and NAFLD. Study Design and Participants: This was a double-blind, randomized, placebo-controlled clinical trial conducted at Arash General Women's Hospital. Ninety-four women of reproductive age diagnosed with PCOS and NAFLD were enrolled and randomly assigned to receive curcumin or placebo. Intervention: Participants in the intervention group received 1000 mg curcumin daily; the control group received 1000 mg placebo daily. The treatment period was 12 weeks. Measurements were taken at baseline and after 12 weeks. Key measurements: Anthropometric measurements, lipid profile (total cholesterol, LDL, HDL, triglycerides), fasting blood glucose, HbA1c, serum testosterone, anti-mullerian hormone (AMH), liver enzymes (AST, ALT, ALP), and liver ultrasound for degree of steatosis.
Interventions
DRUGPatients (women of reproductive age suffering from non-alcoholic fatty liver with polycystic ovary syndrome) receiving 500 mg curcumin capsules (prepared from the extraction of turmeric in the laborat
Patients (women of reproductive age suffering from non-alcoholic fatty liver with polycystic ovary syndrome) receiving 500 mg curcumin capsules (prepared from the extraction of turmeric in the laboratory of Shahid Beheshti Faculty of Pharmacy in Tehran), twice a day (one gram per day) for three months
Sponsors
Fateme Moshirenia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Women of reproductive age from 18 to 45 years old Women with polycystic ovary syndrome and non-alcoholic fatty liver disease Having two of the three Rotterdam criteria including: Having an ultrasound appearance of polycystic ovaries, having serum hyperandrogenism with/without clinical symptoms related to hyperandrogenism such as acne, hirsutism, acanthosis nigricans, etc., having an ovulation disorder and irregular menstrual cycle. Ability to speak and write in Persian
Exclusion criteria
-Pregnancy Breastfeeding Using hormonal methods for contraception Having any other diagnosed disease Sensitivity to turmeric History of advanced chronic liver disease Smoking and alcohol use Drug addiction Adrenal hyperplasia that has symptoms similar to polycystic ovary syndrome Kidney failure or any active digestive disorder Other chronic non-metabolic diseases Thyroid disease Hyperprolactinemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The level of alkaline phosphatase (ALP) | Before the intervention and 48 hours after the intervention | laboratory test |
| Liver ultrasound view (gradient change) | Before the intervention and 48 hours after the end of the intervention | There is no need to fast, and as soon as possible, the patient is referred to an ultrasound specialist for diagnostic and examination procedures according to specific criteria for examining fatty liver. |
| Body mass index (BMI) | Before the intervention and 48 hours after the end of the intervention | Measuring height with a centimeter tape and measuring weight with a digital scale and then entering the obtained values into the formula of weight in kilograms divided by the square of height in meters to calculate the body mass index. |
| The level of low-density lipoprotein (LDL) | before the intervention and 48 hours after the intervention | laboratory test |
| The level of high-density lipoprotein (HDL) | before the intervention and 48 hours after the intervention | laboratory test |
| The level of triglyceride (TG) | before the intervention and 48 hours after the intervention | laboratory test |
| The level of cholesterol | before the intervention and 48 hours after the intervention | laboratory test |
| The level of alanine aminotransferase (ALT) | before the intervention and 48 hours after the intervention | laboratory test |
| The level aspartate aminotransferase (AST) | Before the intervention and 48 hours after the intervention | laboratory test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The level of anxiety | Before the intervention and after the intervention | With the history of taking and filling the DASS questionnaire |
Countries
Iran
Outcome results
None listed