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Completed

NCT Number: NCT03786523

Time Restricted Feeding on Nonalcoholic Fatty Liver Disease

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).

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Time restricted feeding

Behavioral

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).

Continuous Energy Restriction

Behavioral

Participants will follow receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women, without restriction on feeding time.

Primary outcomes

  1. Change in intrahepatic fat content

    Time frame: Baseline and months 6

    Intrahepatic fat content will be assessed by MR mDixon-Quant

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

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

Acronym: TREATY-FLD

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 26, 2018
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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