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

Karachi Medical and Dental College

Status: Completed

Conditions: Weight Loss; Polycystic Ovarian Syndrome; Intermittent Fasting

Treatments: Behavioral: intermittent fasting; Behavioral: Caloric restriction

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT04452968

33

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

intermittent fasting

Experimental group

Description:

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.

Treatment:

Behavioral: intermittent fasting

Behavioral: Caloric restriction

caloric restriction

Active Comparator group

Description:

Daily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories.

Treatment:

Behavioral: Caloric restriction