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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03786523
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : June 14, 2019
Information provided by (Responsible Party):
Huijie Zhang, Nanfang Hospital of Southern Medical University

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).

Condition or disease Intervention/treatment Phase
Nonalcoholic Fatty Liver Disease Behavioral: Time restricted feeding Behavioral: Continuous Energy Restriction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Time-Restricted Feeding on Nonalcoholic Fatty Liver Disease in Obese Adults: a Randomized Clinical Trial
Actual Study Start Date : April 19, 2019
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : October 30, 2020

Arm Intervention/treatment
Experimental: TRF
Time Restricted Feeding
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).

Active Comparator: CER
Continuous Energy Restriction
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.

Primary Outcome Measures :
  1. Change in intrahepatic fat content [ Time Frame: Baseline and months 6 ]
    Intrahepatic fat content will be assessed by MR mDixon-Quant

Secondary Outcome Measures :
  1. Change in liver fiber [ Time Frame: Baseline and months 6 ]
    Liver fiber will be assessed by liver Fibrotouch

  2. Change in visceral fat [ Time Frame: Baseline and months 6 ]
    Visceral fat will be assessed by abdominal CT scan

  3. Change in body fat [ Time Frame: Baseline and months 6 ]
    Body fat will be assessed by whole-body dual x-ray system

  4. Change in waist circumference [ Time Frame: Baseline and months 6 ]
  5. Change in body weight [ Time Frame: Baseline and months 6 ]
  6. Change in HbA1c level [ Time Frame: Baseline and months 6 ]
  7. Change in Systolic blood pressure [ Time Frame: Baseline and months 6 ]
  8. Change in LDL-c level [ Time Frame: Baseline and months 6 ]
  9. Change in serum ALT level [ Time Frame: Baseline and months 6 ]
  10. Change in insulin sensitivity [ Time Frame: Baseline and months 6 ]
    Insulin sensitivity will be assessed by HOMA-IR

  11. Change in β cell function [ Time Frame: Baseline and months 6 ]
    β cell function will be assessed by HOMA-β

  12. Change in pulse wave velocity (PWV) [ Time Frame: Baseline and months 6 ]
  13. Depression measured by the Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline and months 6 ]
    Scores of PHQ-9

  14. Quality of sleep measured by the Pittsburgh sleep quality index (PSQI) [ Time Frame: Baseline and months 6 ]
    Scores of PSQI

  15. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT03786523

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Contact: Huijie Zhang, MD,PhD +86-020-61641635
Contact: Yikai Xu, MD,PhD +86-020-61641635

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China, Guangdong
Nanfang Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Huijie Zhang, MD,PhD         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
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Study Chair: Huijie Zhang, MD,PhD Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University

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Responsible Party: Huijie Zhang, Clinical professor, Nanfang Hospital of Southern Medical University Identifier: NCT03786523     History of Changes
Other Study ID Numbers: NFEC-2018-160
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
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 Huijie Zhang, Nanfang Hospital of Southern Medical University:
Nonalcoholic Fatty Liver Disease
Time restricted feeding
Calorie restriction
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases