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Clinical Trials/NCT03786523
NCT03786523CompletedNot Applicable

Effects of Time-Restricted Feeding on Nonalcoholic Fatty Liver Disease in Obese Adults: a Randomized Clinical Trial

Nanfang Hospital, Southern Medical University1 site in 1 country88 target enrollmentStarted: April 19, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
88
Locations
1
Primary Endpoint
Change in intrahepatic fat content
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • •History of alcoholic liver disease, chronic viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, cirrhosis, and liver cancer;
  • •History of HIV, or active pulmonary tuberculosis;
  • •Diagnosis of type 1 and type 2 diabetes;
  • •History of malignant tumors;
  • •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);
  • •Significant alcohol consumption in the past six months (Consumed more than 20 g/day for women or 30 g/day for men);
  • •History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
  • •History of severe gastrointestinal diseases or gastrointestinal surgery in the past 12 months;
  • •History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity;
  • •Being a smoker or having been a smoker in the 3 months prior to their screening visit;
  • •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;
  • •Currently participating in weight loss programs or weight change in the past 3 months (> 5% current body weight) ;
  • •Women who are pregnant or plan to become pregnant;
  • •Patients who cannot be followed for 24 months (due to a health situation or migration);
  • •Patients who are unwilling or unable to give informed consent.

Outcomes

Primary Outcomes

Change in intrahepatic fat content

Time Frame: Baseline and months 6

Intrahepatic fat content will be assessed by MR mDixon-Quant

Secondary Outcomes

  • Change in body fat(Baseline and months 6)
  • Change in HbA1c level(Baseline and months 6)
  • Change in insulin sensitivity(Baseline and months 6)
  • Change in liver fiber(Baseline and months 6)
  • Change in visceral fat(Baseline and months 6)
  • Change in waist circumference(Baseline and months 6)
  • Change in body weight(Baseline and months 6)
  • Change in Systolic blood pressure(Baseline and months 6)
  • Change in LDL-c level(Baseline and months 6)
  • Change in serum ALT level(Baseline and months 6)
  • Change in pulse wave velocity (PWV)(Baseline and months 6)
  • Depression measured by the Patient Health Questionnaire-9 (PHQ-9)(Baseline and months 6)
  • Quality of sleep measured by the Pittsburgh sleep quality index (PSQI)(Baseline and months 6)
  • Change in β cell function(Baseline and months 6)
  • Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)(Baseline and months 6)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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