Effect of low-calorie Dietary Approaches to Stop Hypertension diet (DASH) and synbiotic supplement on women with polycystic ovary syndrome

Phase 3

Recruiting

Conditions: Women with polycystic ovary syndrome.

Registration Number: IRCT20230220057464N1

Lead Sponsor: Ahvaz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 76

Inclusion Criteria

Age between 18 and 45 years
Body mass index between 27-35
Diagnosis and confirmation of polycystic ovary syndrome by an endocrinologist based on the Rotterdam criteria
Not having conditions such as pregnancy, breastfeeding and menopause
Not taking probiotics or synbiotics in the last three months
Not suffering from other causes of hyperandrogenism such as congenital adrenal hyperplasia, Cushing's syndrome, ovarian or adrenal tumor
Not suffering from hypothyroidism
No diabetes

Exclusion Criteria

Reluctance to cooperate
Following special diets

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CRP, HBA1C, GSH, AMH, insulin, leptin and testosterone, fasting glucose, TG, HDL-C, TC, LDL-C, visceral obesity index, insulin resistance, insulin sensitivity, AIP and VAI, malondialdehyde. Timepoint: All outcomes will be measured at the beginning of the study and at the end of the 12 weeks of the study. Method of measurement: CRP, HBA1C, GSH, AMH, insulin, leptin and testosterone by ELISA method, fasting glucose, TG, HDL-C, TC by photometric method, LDL-C, visceral obesity index, insulin resistance, insulin sensitivity, AIP and VAI They will be measured using the relevant formulas. Malondialdehyde will be measured by TBARS method.

Secondary Outcome Measures

Name	Time	Method
Weight, BMI, waist circumference, hip circumference, ratio of waist circumference to hip circumference, hirsutism rate, sleep quality, alopecia rate and appetite rate. Timepoint: The beginning of the study and 12 weeks after the start of the intervention (the end of the study). Method of measurement: Weight using a scale. BMI using the formula. Waist circumference, hip circumference, ratio of waist circumference to circumference using a meter, amount of hirsutism, quality of sleep, amount of alopecia, and amount of appetite, respectively, using questionnaires of hirsutism, quality of Pittsburgh sleep, alopecia, and appetite.