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Time-Restricted Feeding(TRF) on Overweight/Obese Women With Polycystic Ovarian Syndrome (PCOS) (TRF-PCOS)

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ClinicalTrials.gov Identifier: NCT03792282
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital of Xiamen University

Tracking Information
First Submitted Date  ICMJE December 30, 2018
First Posted Date  ICMJE January 3, 2019
Last Update Posted Date January 3, 2020
Actual Study Start Date  ICMJE January 7, 2019
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 31, 2018)
  • Changes in body weight (Kilograms) [ Time Frame: Baseline and 16 weeks ]
    Changes in body weight (Kilograms)
  • Change in insulin resistance [ Time Frame: Baseline and 16 weeks ]
    Insulin resistance will be assessed by HOMA-IR
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2019)
  • Changes in waist circumference (cm) [ Time Frame: Baseline and 16 weeks ]
  • Changes in abdominal circumference (cm) [ Time Frame: Baseline and 16 weeks ]
  • Changes in systolic pressure(SBP) [ Time Frame: Baseline and 16 weeks ]
  • Changes in diastolic pressure (DBP) [ Time Frame: Baseline and 16 weeks ]
  • Change in β cell function [ Time Frame: Baseline and 16 weeks ]
    β cell function will be assessed by HOMA-β
  • Change in LDL-c level [ Time Frame: Baseline and 16 weeks ]
  • Change in TG level [ Time Frame: Baseline and 16 weeks ]
  • Change in CHO level [ Time Frame: Baseline and 16 weeks ]
  • Change in liver fiber [ Time Frame: Baseline and 16 weeks ]
    liver fiber will be assessed by Controlled attenuation parameter (CAP) evaluated with transient elastography (FibroScan®) Fibroscan
  • Changes in systemic Inflammatory biomarkers [ Time Frame: Baseline and 16 weeks ]
    Inflammatory biomarkers (TNFa,CRP and Interleukin-6) are measured by ELISA (enzyme-linked immunosorbent assay).
  • Changes in Oxidative stress markers [ Time Frame: Baseline and 16 weeks ]
    Oxidative stress markers include the circulating levels of Catalase,Glutathione Peroxidase, and Malondialdehyde.
  • Change in depressive symptoms as assessed by Patient Health Questionnaire-9 [ Time Frame: Baseline and 16 weeks ]
  • Change in quality of life measured by the 12-item Short-Form Health Survey Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12) [ Time Frame: Baseline and 16 weeks ]
  • Changes in time to return to normal menstrual cycle [ Time Frame: Baseline and 16 weeks ]
    Changes in time to return to normal menstrual cycle
Original Secondary Outcome Measures  ICMJE
 (submitted: December 31, 2018)
  • Changes in waist circumference (cm) [ Time Frame: Baseline and 16 weeks ]
  • Changes in abdominal circumference (cm) [ Time Frame: Baseline and 16 weeks ]
  • Changes in systolic pressure(SBP) [ Time Frame: Baseline and 16 weeks ]
  • Changes in diastolic pressure (DBP) [ Time Frame: Baseline and 16 weeks ]
  • Change in β cell function [ Time Frame: Baseline and 16 weeks ]
    β cell function will be assessed by HOMA-β
  • Change in LDL-c level [ Time Frame: Baseline and 16 weeks ]
  • Change in TG level [ Time Frame: Baseline and 16 weeks ]
  • Change in CHO level [ Time Frame: Baseline and 16 weeks ]
  • Change in liver fiber [ Time Frame: Baseline and 16 weeks ]
    liver fiber will be assessed by Controlled attenuation parameter (CAP) evaluated with transient elastography (FibroScan®) Fibroscan
  • Changes in systemic Inflammatory biomarkers [ Time Frame: Baseline and 16 weeks ]
    Inflammatory biomarkers (TNFa,CRP and Interleukin-6) are measured by ELISA (enzyme-linked immunosorbent assay).
  • Changes in Oxidative stress markers [ Time Frame: Baseline and 16 weeks ]
    Oxidative stress markers include the circulating levels of Catalase,Glutathione Peroxidase, and Malondialdehyde.
  • Depression measured by the Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline and 16 weeks ]
  • Quality of life measured by the 12-item Short-Form Health Survey Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12) [ Time Frame: Baseline and 16 weeks ]
  • Changes in time to return to normal menstrual cycle [ Time Frame: Baseline and 16 weeks ]
    Changes in time to return to normal menstrual cycle
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Time-Restricted Feeding(TRF) on Overweight/Obese Women With Polycystic Ovarian Syndrome (PCOS)
Official Title  ICMJE Effectiveness of Time-Restricted Feeding(TRF) on Overweight/Obese Women With Polycystic Ovarian Syndrome(PCOS): A Randomized Controlled Trial
Brief Summary The aims of the present study is to examine whether Time-Restricted Feeding (TRF) is a safe and effective regimen to improve insulin resistance and decrease body weight in overweight/obese Polycystic ovary syndrome (PCOS) patients over 16 weeks compared to reduced energy restriction.
Detailed Description Intermittent fasting regimens involve periods fasting followed by periods of eating freely. Time-Restricted Feeding (TRF) is a new form of intermittent fasting and involves shortening the eating window to 4-10 h/day. TRF is a safe lifestyle intervention for weight loss in adults with obesity. Accumulating evidence suggests that TRF is an effective means of decreasing body weight and improving insulin resistance but did not have any negative impact on eating disorder symptoms, body image perception, or eating behaviors. Polycystic ovary syndrome (PCOS) is the most common endocrine condition in productive-aged women. About 60-70 % of women with PCOS are obese or overweight, and obesity is associated with insulin resistance. Since many women with PCOS seem to have insulin resistance, compensatory hyperinsulinemia is thought to contribute to hyperandrogenism by direct stimulation of ovarian production of androgens and by inhibition of liver synthesis of SHGB. It is important to ameliorate insulin resistance in PCOS patients.The aims of the present study is to examine whether TRF is a safe and effective regimen to improve insulin resistance and decrease body weight in overweight/obese PCOS patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Polycystic Ovary Syndrome (PCOS)
  • Overweight and Obesity
Intervention  ICMJE
  • Behavioral: Time Restricted Feeding
    Participants will receive a diet of 1200-1500kcal/d and be instructed to eat only during a window of 8 hours (Finishing the last meal before 4pm).
  • Behavioral: Reduced Calorie Diet (RCD)
    Participants will receive a diet of 1200-1500kcal/d and keep their usual eating pattern.
Study Arms  ICMJE
  • Experimental: TRF
    Participants in this group will focus on time restricted feeding (TRF) in addition to daily calorie restriction.
    Intervention: Behavioral: Time Restricted Feeding
  • Active Comparator: RCD
    Participants in this group will focus on daily reduced calorie diet (RCD).
    Intervention: Behavioral: Reduced Calorie Diet (RCD)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 31, 2018)
76
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years
  • BMI≥24kg/m2
  • Polycystic ovary syndrome has been diagnosed

Exclusion Criteria:

  • 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;
  • Having been in pregnancy.
  • Researchers believe that there are any factors that affect assessing subjects' participation in trial.
  • History of malignant tumors;
  • History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity;
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Only women have the PCOS.
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Changqin Liu, MD +8613376986106 ext +8613376986106 liuchangqin@xmu.edu.cn
Contact: Huijie Zhang, MD +86-159-5923-8193 ext +86-15959238 huijiezhang2005@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03792282
Other Study ID Numbers  ICMJE KYH2018-017
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The First Affiliated Hospital of Xiamen University
Study Sponsor  ICMJE The First Affiliated Hospital of Xiamen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Changqin Liu, MD The first afilliated hospital of Xiamen university
PRS Account The First Affiliated Hospital of Xiamen University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP