Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04452968
Other study ID # 33
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2020
Est. completion date October 30, 2020

Study information

Verified date November 2020
Source Karachi Medical and Dental College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date October 30, 2020
Est. primary completion date October 30, 2020
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 35 Years
Eligibility 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

Study Design


Intervention

Behavioral:
intermittent fasting
Women were required to fast for 16 hours and consume their allotted calories during the remaining 8 hours.
Caloric restriction
Daily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories.

Locations

Country Name City State
Pakistan Aziz Medical Center Karachi Sindh

Sponsors (2)

Lead Sponsor Collaborator
Karachi Medical and Dental College Aziz Medical Center

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary weight loss in kg in 3 months
Secondary decrease in body fat percentage in 3 months
Secondary fasting plasma insulin in 3 months
Secondary blood pressure in mm Hg in 3 months
See also
  Status Clinical Trial Phase
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Active, not recruiting NCT04420936 - Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program N/A
Terminated NCT03316105 - Effect of T6 Dermatome Electrical Stimulation on Gastroduodenal Motility in Healthy Volunteers N/A
Completed NCT03700736 - The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups N/A
Active, not recruiting NCT04353726 - Knowledge-based Dietary Weight Management. N/A
Completed NCT02948283 - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia Phase 1
Completed NCT03377244 - Healthy Body Healthy Souls in the Marshallese Population N/A
Completed NCT02877004 - LLLT for Reducing Waste Circumference and Weight N/A
Active, not recruiting NCT04327141 - Low Sugar Protein Pacing, Intermittent Fasting Diet in Men and Women N/A
Completed NCT03929198 - Translation of Pritikin Program to the Community N/A
Recruiting NCT05249465 - Spark: Finding the Optimal Tracking Strategy for Weight Loss in a Digital Health Intervention N/A
Recruiting NCT05942326 - Sleep Goal-focused Online Access to Lifestyle Support N/A
Completed NCT00535600 - Effects of Bariatric Surgery on Insulin
Not yet recruiting NCT03601273 - Bariatric Embolization Trial for the Obese Nonsurgical Phase 1
Active, not recruiting NCT04357119 - Common Limb Length in One-anastomosis Gastric Bypass N/A
Completed NCT02945410 - Effect of Caloric Restriction and Protein Intake on Metabolism and Anabolic Sensitivity N/A
Completed NCT03210207 - Gastric Plication in Mexican Patients N/A
Completed NCT02948517 - Time Restricted Feeding for Weight Loss and Cardio-protection N/A
Completed NCT03139760 - POWERSforID: A Telehealth Weight Management System for Adults With Intellectual Disability N/A
Recruiting NCT02559479 - A Study to Assess the Effect of a Normal vs. High Protein Diets in Carbohydrates Metabolism in Obese Subjects With Diabetes or Prediabetes N/A