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

Intermittent Fasting and Polycystic Ovarian Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss; Polycystic Ovarian Syndrome; Intermittent Fasting
• Intervention / Treatment: Behavioral: intermittent fasting; Behavioral: Caloric restriction

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74600
      • Aziz medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
weight loss in kg	in 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Karachi Medical and Dental College
• Collaborators: Aziz Medical Center
• Investigators: Study Chair: Rubina Izhar, Aziz medical center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: June 26, 2020
• First Submitted That Met QC Criteria: June 26, 2020
• First Posted (Actual): July 1, 2020

Study Record Updates

• Last Update Posted (Actual): November 25, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Body Weight; Body Weight Changes; Polycystic Ovary Syndrome; Syndrome; Weight Loss
• Other Study ID Numbers: 33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No