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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04452968
Recruitment Status : Recruiting
First Posted : July 1, 2020
Last Update Posted : July 9, 2020
Sponsor:
Collaborator:
Aziz Medical Center
Information provided by (Responsible Party):
samia husain, Karachi Medical and Dental College

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intermittent Fasting and Polycystic Ovarian Syndrome
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : October 15, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. weight loss [ Time Frame: in 3 months ]

Secondary Outcome Measures :
  1. decrease in body fat percentage [ Time Frame: in 3 months ]
  2. fasting plasma insulin [ Time Frame: in 3 months ]
  3. blood pressure [ Time Frame: in 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PCOS as described by Rotterdam's criteria

Exclusion Criteria:

  • endocrine disorders
  • diabetic
  • hypertensive

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452968


Contacts
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Contact: Samia Husain +923353431452 samiahusain_scorpio@hotmail.com

Locations
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Pakistan
Aziz Medical Center Recruiting
Karachi, Sindh, Pakistan, 74600
Contact: Samia Husain       samiahusain_scorpio@hotmail.com   
Sponsors and Collaborators
Karachi Medical and Dental College
Aziz Medical Center
Investigators
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Study Chair: Rubina Izhar Aziz Medical Center
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Responsible Party: samia husain, clinical investigator, Karachi Medical and Dental College
ClinicalTrials.gov Identifier: NCT04452968    
Other Study ID Numbers: 33
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Weight Loss
Disease
Pathologic Processes
Body Weight
Signs and Symptoms
Body Weight Changes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases