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Completed

NCT Number: NCT04452968

Comparison of Intermittent Fasting and Caloric Deficit for Weight Loss in Women With 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.

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Key information

Conditions

Polycystic Ovarian Syndrome Adnexal Diseases Behavior Body Weight Body Weight Changes Cysts Endocrine System Diseases Fasting Feeding Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Intermittent Fasting Neoplasms Ovarian Cysts Ovarian Diseases Pathological Conditions, Signs and Symptoms Polycystic Ovary Syndrome Signs and Symptoms Urogenital Diseases Weight Loss

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aziz Medical Center

Karachi, Sindh, 74600, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent fasting

Behavioral

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

Caloric restriction

Behavioral

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

Primary outcomes

  1. weight loss in kg

    Time frame: in 3 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Karachi Medical and Dental College

Other

Collaborators

  • Aziz Medical Center

Registry information

Official study title

Intermittent Fasting and Polycystic Ovarian Syndrome

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 1, 2020
Registry last updated
Nov 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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