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Effect of Yoghurt Fortified with Probiotics and Vitamins D and E in Treatment of Polycystic Ovary Syndrome

The Effect of Yoghurt Fortified with Probiotics and Vitamins D and E on Anthropometric and Biochemical Indices, Blood Pressure, Sleep Quality, and Mental Health in Patients with Polycystic Ovary Syndrome: A Randomized, Double-Blind, Controlled Clinical Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231210060323N1
Enrollment
90
Registered
2023-12-14
Start date
2024-01-21
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Polycystic ovary syndrome. Polycystic ovarian syndrome

Interventions

Intervention 1: Intervention group: Intaking120 grams per day of low-fat yogurt containing vitamin D (with a dose of 1000 IU or 25 micrograms) and vitamin E (with a dose of 50 IU or 34 mg) and two pro

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Willingness to cooperate in the study and provide written consent Being in the reproductive age range of 18-45 years Diagnosis of polycystic ovary syndrome based on the Rotterdam criteria No intake of alcohol or drugs Not pregnant or breastfeeding No menopause No participate in other research studies

Exclusion criteria

Exclusion criteria: Using drugs affecting blood pressure, blood lipids, ovarian function, insulin sensitivity (including metformin, incretin, and Thiazolidinediones) and oral contraceptives (including progesterone and estrogen) since 3 months before entering the study. Taking any nutritional supplements for 3 months before entering the study Taking drugs affecting vitamin D metabolism having diabetes, thyroid disease or any systemic disease (such as kidney, liver, digestive system, cardiovascular system) Having disorders that lead to an increase in androgens in the blood (such as Cushing's syndrome, hyperprolactinemia)

Design outcomes

Primary

MeasureTime frame
Homeostasis model assessment of insulin resistance. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Formula.

Secondary

MeasureTime frame
Weight. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Scale.;Body Mass Index. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Formula.;Waist Circumference. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Stadiometer.;Hip Circumference. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Stadiometer.;Waist to Hip Ratio. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Formula.;Systolic Blood Pressure. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Electronic Sphygmomanometer.;Diastolic Blood Pressure. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Electronic Sphygmomanometer.;Fasting Blood Sugar. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: Pars Azmoon Kit.;Fasting Insulin. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention). Method of measurement: ELISA Kit.;The Quantitative Insulin Sensitivity Check Index. Timepoint: At the beginning of the st

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMoein Askarpour

Shiraz University of Medical Sciences

askarpourmoein1994@gmail.com+98 71 3725 1001

Outcome results

None listed

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