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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04452968
Recruitment Status : Completed
First Posted : July 1, 2020
Last Update Posted : November 25, 2020
Sponsor:
Collaborator:
Aziz Medical Center
Information provided by (Responsible Party):
samia husain, Karachi Medical and Dental College

Tracking Information
First Submitted Date  ICMJE June 26, 2020
First Posted Date  ICMJE July 1, 2020
Last Update Posted Date November 25, 2020
Actual Study Start Date  ICMJE July 1, 2020
Actual Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2020)
weight loss in kg [ Time Frame: in 3 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2020)
weight loss [ Time Frame: in 3 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2020)
  • decrease in body fat percentage [ Time Frame: in 3 months ]
  • fasting plasma insulin [ Time Frame: in 3 months ]
  • blood pressure in mm Hg [ Time Frame: in 3 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2020)
  • decrease in body fat percentage [ Time Frame: in 3 months ]
  • fasting plasma insulin [ Time Frame: in 3 months ]
  • blood pressure [ Time Frame: in 3 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Intermittent Fasting and Caloric Deficit for Weight Loss in Women With Polycystic Ovarian Syndrome
Official Title  ICMJE Intermittent Fasting and Polycystic Ovarian Syndrome
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Polycystic Ovarian Syndrome
  • Weight Loss
  • Intermittent Fasting
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.

    Interventions:
    • Behavioral: intermittent fasting
    • Behavioral: Caloric restriction
  • 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.
    Intervention: Behavioral: Caloric restriction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 23, 2020)
96
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2020)
100
Actual Study Completion Date  ICMJE October 30, 2020
Actual Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: females
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04452968
Other Study ID Numbers  ICMJE 33
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party samia husain, Karachi Medical and Dental College
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Karachi Medical and Dental College
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Aziz Medical Center
Investigators  ICMJE
Study Chair: Rubina Izhar Aziz Medical Center
PRS Account Karachi Medical and Dental College
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP