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

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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

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)
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 : July 1, 2020
Actual Primary Completion Date : October 30, 2020
Actual Study Completion Date : October 30, 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 in kg [ 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 in mm Hg [ Time Frame: in 3 months ]


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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   females
Accepts Healthy Volunteers:   No
Criteria

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

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


Locations
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Pakistan
Aziz Medical Center
Karachi, Sindh, Pakistan, 74600
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: November 25, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Body Weight Changes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases