Time Restricted Feeding on Nonalcoholic Fatty Liver Disease ( TREATY-FLD )：a 12-month Follow-up Study

Nonalcoholic Fatty Liver Disease Clinical Trial

— TREATY-FLD  

Official title:

Effects of Time-Restricted Feeding on Nonalcoholic Fatty Liver Disease in Obese Adults: a 12-month Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04988230
• Other study ID #: NFEC-2018-160R
• Status: Completed
• Phase: N/A
• Start date: July 30, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: April 2022
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 6-month follow-up study of TREATY-FLD 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease

Intervention

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).
• 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.

Locations

Country	Name	City	State
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in intrahepatic fat content	Intrahepatic fat content will be assessed by MR mDixon-Quant	Baseline,month 6, month 12.
Secondary	Change in liver fiber	Liver fiber will be assessed by liver Fibrotouch	Baseline,month 6, month 12.
Secondary	Change in visceral fat	Visceral fat will be assessed by abdominal CT scan	Baseline,month 6, month 12.
Secondary	Change in body fat	Body fat will be assessed by whole-body dual x-ray system	Baseline,month 6, month 12.
Secondary	Change in waist circumference		Baseline,month 6, month 12.
Secondary	Change in body weight		Baseline,month 6, month 12.
Secondary	Change in HbA1c level		Baseline,month 6, month 12.
Secondary	Change in Systolic blood pressure		Baseline,month 6, month 12.
Secondary	Change in LDL-c level		Baseline,month 6, month 12.
Secondary	Change in serum ALT level		Baseline,month 6, month 12.
Secondary	Change in insulin sensitivity	Insulin sensitivity will be assessed by HOMA-IR	Baseline,month 6, month 12.