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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

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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome (PCOS) Overweight and Obesity Behavioral: Time Restricted Feeding Behavioral: Reduced Calorie Diet (RCD) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effectiveness of Time-Restricted Feeding(TRF) on Overweight/Obese Women With Polycystic Ovarian Syndrome(PCOS): A Randomized Controlled Trial
Actual Study Start Date : January 7, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TRF
Participants in this group will focus on time restricted feeding (TRF) in addition to daily calorie restriction.
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).

Active Comparator: RCD
Participants in this group will focus on daily reduced calorie diet (RCD).
Behavioral: Reduced Calorie Diet (RCD)
Participants will receive a diet of 1200-1500kcal/d and keep their usual eating pattern.




Primary Outcome Measures :
  1. Changes in body weight (Kilograms) [ Time Frame: Baseline and 16 weeks ]
    Changes in body weight (Kilograms)

  2. Change in insulin resistance [ Time Frame: Baseline and 16 weeks ]
    Insulin resistance will be assessed by HOMA-IR


Secondary Outcome Measures :
  1. Changes in waist circumference (cm) [ Time Frame: Baseline and 16 weeks ]
  2. Changes in abdominal circumference (cm) [ Time Frame: Baseline and 16 weeks ]
  3. Changes in systolic pressure(SBP) [ Time Frame: Baseline and 16 weeks ]
  4. Changes in diastolic pressure (DBP) [ Time Frame: Baseline and 16 weeks ]
  5. Change in β cell function [ Time Frame: Baseline and 16 weeks ]
    β cell function will be assessed by HOMA-β

  6. Change in LDL-c level [ Time Frame: Baseline and 16 weeks ]
  7. Change in TG level [ Time Frame: Baseline and 16 weeks ]
  8. Change in CHO level [ Time Frame: Baseline and 16 weeks ]
  9. 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

  10. 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).

  11. Changes in Oxidative stress markers [ Time Frame: Baseline and 16 weeks ]
    Oxidative stress markers include the circulating levels of Catalase,Glutathione Peroxidase, and Malondialdehyde.

  12. Change in depressive symptoms as assessed by Patient Health Questionnaire-9 [ Time Frame: Baseline and 16 weeks ]
  13. 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 ]
  14. Changes in time to return to normal menstrual cycle [ Time Frame: Baseline and 16 weeks ]
    Changes in time to return to normal menstrual cycle



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only women have the PCOS.
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03792282


Contacts
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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

Locations
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China, Fujian
The first afilliated hospital of Xiamen university Recruiting
Xiamen, Fujian, China, 361003
Contact: Changqin Liu, MD    +86-133 7698 6106    liuchangqin@xmu.edu.cn   
Sponsors and Collaborators
The First Affiliated Hospital of Xiamen University
Investigators
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Principal Investigator: Changqin Liu, MD The first afilliated hospital of Xiamen university
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Responsible Party: The First Affiliated Hospital of Xiamen University
ClinicalTrials.gov Identifier: NCT03792282    
Other Study ID Numbers: KYH2018-017
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 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
Keywords provided by The First Affiliated Hospital of Xiamen University:
Polycystic Ovary Syndrome
Overweight and Obesity
Time-Restricted Feeding
Intermittent fasting regimens
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Overweight
Disease
Pathologic Processes
Body Weight
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases