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

Weight Loss Clinical Trial

Official title:

Intermittent Fasting and Polycystic Ovarian Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04452968
• Other study ID #: 33
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: November 2020
• Source: Karachi Medical and Dental College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Intermittent Fasting
• Polycystic Ovarian Syndrome
• Polycystic Ovary Syndrome
• Syndrome
• Weight Loss

Intervention

Behavioral:
• intermittent fasting
Women were required to fast for 16 hours and consume their allotted calories during the remaining 8 hours.
• Caloric restriction
Daily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories.

Locations

Country	Name	City	State
Pakistan	Aziz Medical Center	Karachi	Sindh

Sponsors (2)

Lead Sponsor	Collaborator
Karachi Medical and Dental College	Aziz Medical Center

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss in kg		in 3 months
Secondary	decrease in body fat percentage		in 3 months
Secondary	fasting plasma insulin		in 3 months
Secondary	blood pressure in mm Hg		in 3 months