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

Effect of low-calorie Dietary Approaches to Stop Hypertension diet (DASH) and synbiotic supplement on metabolic risk factors, serum levels of some inflammatory, oxidant factors and antimullerin hormone in women with polycystic ovary syndrome

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230220057464N1

Enrollment

Registered

2023-02-23

Start date

2023-02-21

Completion date

Unknown

Last updated

2023-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women with polycystic ovary syndrome.

Interventions

Intervention group: Intervention group: 1- group receiving low-calorie DASH diet + synbiotic supplement (500 mg per day) 2- group receiving low-calorie DASH diet + placebo 3- group receiving standard

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

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

Exclusion criteria: Reluctance to cooperate Following special diets

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Farahmandpour

Ahvaz University of Medical Sciences

farahmand901@gmail.com+98 61 3311 0000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026