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

Primary Purpose

Nonalcoholic Fatty Liver Disease

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Time restricted feeding

Continuous Energy Restriction

About this trial

This is an interventional treatment trial for Nonalcoholic Fatty Liver Disease focused on measuring Nonalcoholic Fatty Liver Disease, Time restricted feeding, Calorie restriction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Nanfang Hospital of Southern Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Time Restricted Feeding

Continuous Energy Restriction

Arm Description

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).

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

Outcomes

Primary Outcome Measures

Change in intrahepatic fat content

Intrahepatic fat content will be assessed by MR mDixon-Quant

Secondary Outcome Measures

Change in liver fiber

Liver fiber will be assessed by liver Fibrotouch

Change in visceral fat

Visceral fat will be assessed by abdominal CT scan

Change in body fat

Body fat will be assessed by whole-body dual x-ray system

Change in waist circumference

Change in body weight

Change in HbA1c level

Change in Systolic blood pressure

Change in LDL-c level

Change in serum ALT level

Change in insulin sensitivity

Insulin sensitivity will be assessed by HOMA-IR

Full Information

NCT ID

NCT04988230

First Posted

July 31, 2021

Last Updated

April 5, 2022

Sponsor

Nanfang Hospital, Southern Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04988230

Brief Title

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

Acronym

TREATY-FLD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

July 30, 2021 (Actual)

Primary Completion Date

December 30, 2021 (Actual)

Study Completion Date

December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nonalcoholic Fatty Liver Disease

Keywords

Nonalcoholic Fatty Liver Disease, Time restricted feeding, Calorie restriction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Time Restricted Feeding

Arm Type

Experimental

Arm Description

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).

Arm Title

Continuous Energy Restriction

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Time restricted feeding

Intervention Description

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).

Intervention Type

Behavioral

Intervention Name(s)

Continuous Energy Restriction

Intervention Description

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 Measure Information:

Title

Change in intrahepatic fat content

Description

Intrahepatic fat content will be assessed by MR mDixon-Quant

Time Frame

Baseline,month 6, month 12.

Secondary Outcome Measure Information:

Title

Change in liver fiber

Description

Liver fiber will be assessed by liver Fibrotouch

Time Frame

Baseline,month 6, month 12.

Title

Change in visceral fat

Description

Visceral fat will be assessed by abdominal CT scan

Time Frame

Baseline,month 6, month 12.

Title

Change in body fat

Description

Body fat will be assessed by whole-body dual x-ray system

Time Frame

Baseline,month 6, month 12.

Title

Change in waist circumference

Time Frame

Baseline,month 6, month 12.

Title

Change in body weight

Time Frame

Baseline,month 6, month 12.

Title

Change in HbA1c level

Time Frame

Baseline,month 6, month 12.

Title

Change in Systolic blood pressure

Time Frame

Baseline,month 6, month 12.

Title

Change in LDL-c level

Time Frame

Baseline,month 6, month 12.

Title

Change in serum ALT level

Time Frame

Baseline,month 6, month 12.

Title

Change in insulin sensitivity

Description

Insulin sensitivity will be assessed by HOMA-IR

Time Frame

Baseline,month 6, month 12.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Huijie Zhang, MD,PhD

Organizational Affiliation

Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University

Official's Role

Study Chair

Facility Information:

Facility Name

Nanfang Hospital of Southern Medical University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510515

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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