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Study aim
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Determining the combined effect of low-calorie Dietary Approaches to Stop Hypertension diet (DASH) and synbiotic supplement on metabolic risk factors, serum levels of some inflammatory factors, oxidants, and antimullerin hormone in women with polycystic ovary syndrome
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Design
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The clinical trial has four groups, including three intervention groups and one control group, with parallel, double-blind, randomized, phase 3 groups on 76 patients. A table of random numbers will be used for randomization.
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Settings and conduct
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This study will be conducted as a double-blind clinical trial on 76 women aged 18 to 45 in Ahvaz for 12 weeks. The study subjects will be randomly allocated in one of the following four groups:
1- receiving low-calorie Dietary Approaches to Stop Hypertension diet (DASH) + synbiotic supplement (500 mg per day)
2- receiving low-calorie DASH diet + placebo
3- receiving standard low-calorie diet + synbiotic supplement (500 mg per day)
4- receiving standard low-calorie diet + placebo (control group)
Lack of knowledge of the participants and the examiners of the results of the characteristics of the group of people
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Four studied groups
1- receiving low-calorie Dietary Approaches to Stop Hypertension diet (DASH) + synbiotic supplement (500 mg per day)
2- receiving low-calorie DASH diet + placebo
3- receiving standard low-calorie diet + synbiotic supplement (500 mg per day)
4- receiving standard low-calorie diet + placebo (control group)
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Main outcome variables
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CRP, HBA1C, GSH, AMH, insulin, leptin, testosterone, fasting glucose, TG, HDL-C, TC, LDL-C, visceral obesity index, insulin resistance, insulin sensitivity, AIP and VAI, malondialdehyde