Comparison of Intermittent Fasting and Caloric Deficit for Weight Loss in Women With Polycystic Ovarian Syndrome

Study Overview
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Brief Summary
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Time restricted feeding (TRF) has been emerging as a potential weight loss strategy that avoids major dietary changes but achieves strong effects. It also improves insulin sensitivity through increased human growth hormone. This effect helps to improve the root cause of weight gain and has additional benefits for women with PCOS.

Official Title
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Intermittent Fasting and Polycystic Ovarian Syndrome

Conditions
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Polycystic Ovarian Syndrome, Weight Loss, Intermittent Fasting

Intervention / Treatment
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* Behavioral: intermittent fasting
* Behavioral: Caloric restriction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PCOS as described by Rotterdam's criteria Exclusion Criteria: endocrine disorders diabetic hypertensive Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician; The body weight fluctuated more than 5% in recent 3 months. Liver and kidney dysfunction: renal impairment, creatinine clearance rate < 30 mL/min/1.73 m2, transaminase increased, more than three times higher than the normal limit; History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months; History of thyroid diseases; pregnant Currently participating in weight loss programs or weight change in the past 3 months (> 5% current body weight) Patients who cannot be followed for 16 months (due to a health situation or migration) Patients who are unwilling or unable to give informed consent

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intermittent fasting<br>Daily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories. Women were told about timed restricted feeding. They were required to fast for 16 hours and consume their allotted calories during the remaining 8 hours. | Behavioral: intermittent fasting<br>* Women were required to fast for 16 hours and consume their allotted calories during the remaining 8 hours.<br>Behavioral: Caloric restriction<br>* Daily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories.<br>|
| Active Comparator: caloric restriction<br>Daily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories. | Behavioral: Caloric restriction<br>* Daily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss in kg |  | in 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease in body fat percentage |  | in 3 months | 
| fasting plasma insulin |  | in 3 months | 
| blood pressure in mm Hg |  | in 3 months |