Evaluation of the Therapeutic Effects of Curcumin on Changes in Lipid, Metabolic, and Hormonal Profiles, Liver Enzyme Activity, and Ultrasonography Morphology of the Liver in Women With Polycystic Ovary Syndrome and Nonalcoholic Fatty Liver Disease: A Double-blind, Placebo-controlled Clinical Trial

Fateme Moshirenia74 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Polycystic Ovary Syndrome (PCOS) With Concurrent Nonalcoholic Fatty Liver Disease (NAFLD)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Liver ultrasound view (gradient change)

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.

Time frame: Before the intervention and 48 hours after the end of the intervention

Body mass index (BMI)

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.

Time frame: Before the intervention and 48 hours after the end of the intervention

The level of low-density lipoprotein (LDL)

laboratory test