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

Primary Purpose

Polycystic Ovarian Syndrome, Weight Loss, Intermittent Fasting

Status

Completed

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

intermittent fasting

Caloric restriction

About this trial

This is an interventional treatment trial for Polycystic Ovarian Syndrome

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Aziz Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

intermittent fasting

caloric restriction

Arm Description

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.

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

Outcomes

Primary Outcome Measures

weight loss in kg

Secondary Outcome Measures

decrease in body fat percentage

fasting plasma insulin

blood pressure in mm Hg

Full Information

NCT ID

NCT04452968

First Posted

June 26, 2020

Last Updated

November 23, 2020

Sponsor

Karachi Medical and Dental College

Collaborators

Aziz Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04452968

Brief Title

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

Official Title

Intermittent Fasting and Polycystic Ovarian Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

July 1, 2020 (Actual)

Primary Completion Date

October 30, 2020 (Actual)

Study Completion Date

October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karachi Medical and Dental College

Collaborators

Aziz Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovarian Syndrome, Weight Loss, Intermittent Fasting

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

intermittent fasting

Arm Type

Experimental

Arm Description

Arm Title

caloric restriction

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

intermittent fasting

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Caloric restriction

Intervention Description

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

Primary Outcome Measure Information:

Title

weight loss in kg

Time Frame

in 3 months

Secondary Outcome Measure Information:

Title

decrease in body fat percentage

Time Frame

in 3 months

Title

fasting plasma insulin

Time Frame

in 3 months

Title

blood pressure in mm Hg

Time Frame

in 3 months

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

females

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rubina Izhar

Organizational Affiliation

Aziz Medical Center

Official's Role

Study Chair

Facility Information:

Facility Name

Aziz Medical Center

City

Karachi

State/Province

Sindh

ZIP/Postal Code

74600

Country

Pakistan

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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