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

Sponsor

Karachi Medical and Dental College (Other)

Overall Status

Completed

CT.gov ID

NCT04452968

Collaborator

Aziz Medical Center (Other)

Enrollment

Location

Arms

Actual Duration (Months)

24.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovarian Syndrome Weight Loss Intermittent Fasting	Behavioral: intermittent fasting Behavioral: Caloric restriction	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Intermittent Fasting and Polycystic Ovarian Syndrome

Actual Study Start Date :

Jul 1, 2020

Actual Primary Completion Date :

Oct 30, 2020

Actual Study Completion Date :

Oct 30, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: intermittent fasting

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

Women were required to fast for 16 hours and consume their allotted calories during the remaining 8 hours.

Behavioral: Caloric restriction

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

Active Comparator: caloric restriction

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

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

Outcome Measures

Primary Outcome Measures

weight loss in kg [in 3 months]

Secondary Outcome Measures

decrease in body fat percentage [in 3 months]
fasting plasma insulin [in 3 months]
blood pressure in mm Hg [in 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aziz Medical Center	Karachi	Sindh	Pakistan	74600

Sponsors and Collaborators

Karachi Medical and Dental College
Aziz Medical Center

Investigators

Study Chair: Rubina Izhar, Aziz Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

samia husain, clinical investigator, Karachi Medical and Dental College

ClinicalTrials.gov Identifier:

NCT04452968

Other Study ID Numbers:

First Posted:

Jul 1, 2020

Last Update Posted:

Nov 25, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Syndrome

Weight Loss

Study Results

No Results Posted as of Nov 25, 2020