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

Not Applicable

Completed

• Conditions: Intermittent Fasting; Polycystic Ovarian Syndrome; Weight Loss

• Registration Number: NCT04452968
• Lead Sponsor: Karachi Medical and Dental College

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-26
• Study First Submitted QC: 2020-06-26
• Study Start: 2020-07-01
• Study First Posted: 2020-07-01
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
weight loss in kg	in 3 months

Secondary Outcome Measures

Name	Time	Method
decrease in body fat percentage	in 3 months
blood pressure in mm Hg	in 3 months
fasting plasma insulin	in 3 months

Trial Locations

Locations (1)

Aziz Medical Center; 🇵🇰 Karachi, Sindh, Pakistan