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Time Restricted Feeding on Nonalcoholic Fatty Liver Disease (TREATY-FLD)

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ClinicalTrials.gov Identifier: NCT03786523
Recruitment Status : Not yet recruiting
First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Huijie Zhang, Nanfang Hospital of Southern Medical University

Tracking Information
First Submitted Date  ICMJE December 18, 2018
First Posted Date  ICMJE December 25, 2018
Last Update Posted Date December 25, 2018
Estimated Study Start Date  ICMJE January 30, 2019
Estimated Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2018)
Change in intrahepatic fat content [ Time Frame: Baseline and months 6 ]
Intrahepatic fat content will be assessed by MR mDixon-Quant
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2018)
  • Change in liver fiber [ Time Frame: Baseline and months 6 ]
    Liver fiber will be assessed by liver Fibrotouch
  • Change in visceral fat [ Time Frame: Baseline and months 6 ]
    Visceral fat will be assessed by abdominal CT scan
  • Change in body fat [ Time Frame: Baseline and months 6 ]
    Body fat will be assessed by whole-body dual x-ray system
  • Change in waist circumference [ Time Frame: Baseline and months 6 ]
  • Change in body weight [ Time Frame: Baseline and months 6 ]
  • Change in HbA1c level [ Time Frame: Baseline and months 6 ]
  • Change in Systolic blood pressure [ Time Frame: Baseline and months 6 ]
  • Change in LDL-c level [ Time Frame: Baseline and months 6 ]
  • Change in serum ALT level [ Time Frame: Baseline and months 6 ]
  • Change in insulin sensitivity [ Time Frame: Baseline and months 6 ]
    Insulin sensitivity will be assessed by HOMA-IR
  • Change in β cell function [ Time Frame: Baseline and months 6 ]
    β cell function will be assessed by HOMA-β
  • Change in pulse wave velocity (PWV) [ Time Frame: Baseline and months 6 ]
  • Depression measured by the Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline and months 6 ]
    Scores of PHQ-9
  • Quality of sleep measured by the Pittsburgh sleep quality index (PSQI) [ Time Frame: Baseline and months 6 ]
    Scores of PSQI
  • Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12) [ Time Frame: Baseline and months 6 ]
    Scores of SF-12
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Time Restricted Feeding on Nonalcoholic Fatty Liver Disease
Official Title  ICMJE Effects of Time-Restricted Feeding on Nonalcoholic Fatty Liver Disease in Obese Adults: a Randomized Clinical Trial
Brief Summary Time restricted feeding (TRF) is a novel type of intermittent calorie restriction diet that involves eating a daily period of 8 hours or less. This is a randomized controlled trial to evaluate the effect of time restricted feeding (TRF) on hepatic fat contents and cardiometabolic risk factors in obese adults over 6 months compared to continuous energy restriction (CER).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Nonalcoholic Fatty Liver Disease
Intervention  ICMJE
  • Behavioral: Time restricted feeding
    Participants will receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women during a window of 8 h/d (8 am to 4 pm).
  • Behavioral: Continuous Energy Restriction
    Participants will follow receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women, without restriction on feeding time.
Study Arms  ICMJE
  • Experimental: TRF
    Time Restricted Feeding
    Intervention: Behavioral: Time restricted feeding
  • Active Comparator: CER
    Continuous Energy Restriction
    Intervention: Behavioral: Continuous Energy Restriction
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 22, 2018)
86
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2021
Estimated Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Man or women aged≥18 years;
  2. Subjects with NAFLD determined by MRI (intrahepatic triglyceride content ≥5%);
  3. Body mass index (BMI)of 28.0 to 45.0 kg/m2;

Exclusion Criteria:

  1. History of alcoholic liver disease, chronic viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, cirrhosis, and liver cancer;
  2. History of HIV, or active pulmonary tuberculosis;
  3. Diagnosis of type 1 and type 2 diabetes;
  4. History of malignant tumors;
  5. Serious liver dysfunction or chronic kidney disease (AST or ALT > 3 times the upper limit of normal, or eGFR<30 ml/min/1.73 m2);
  6. Significant alcohol consumption in the past six months (Consumed more than 20 g/day for women or 30 g/day for men);
  7. History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
  8. History of severe gastrointestinal diseases or gastrointestinal surgery in the past 12 months;
  9. History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity;
  10. Being a smoker or having been a smoker in the 3 months prior to their screening visit;
  11. 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;
  12. Currently participating in weight loss programs or weight change in the past 3 months (> 5% current body weight) ;
  13. Women who are pregnant or plan to become pregnant;
  14. Patients who cannot be followed for 24 months (due to a health situation or migration);
  15. Patients who are unwilling or unable to give informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Huijie Zhang, MD,PhD +86-020-61641635 Huijiezhang2005@126.com
Contact: Yikai Xu, MD,PhD +86-020-61641635 yikaivip@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03786523
Other Study ID Numbers  ICMJE NFEC-2018-160
Has Data Monitoring Committee No
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 Huijie Zhang, Nanfang Hospital of Southern Medical University
Study Sponsor  ICMJE Nanfang Hospital of Southern Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Huijie Zhang, MD,PhD Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University
PRS Account Nanfang Hospital of Southern Medical University
Verification Date December 2018

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