Effect of Modified Time-restricted Feeding in Preventing Progression of Non-Alcoholic Fatty Liver Disease (NAFLD).

The purpose of the study is to examine the effects of modified time-restricted feeding and conventional dietary approaches in motivated obese fatty liver patients on biochemical markers, imaging studies, and anthropometric measurements.

Study Overview

• Status: Unknown
• Conditions: Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Behavioral: Modified Time-restricted Feeding; Behavioral: Physical activity; Behavioral: Restricted consumption of sweetened beverages; Behavioral: Conventional diet

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Essam M Imseis, MD; Phone Number: 713-500-5663; Email: essam.imseis@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
      • Contact: Essam M Imseis, MD; Phone Number: 713-500-5663; Email: essam.imseis@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Motivated obese fatty liver patients aged 8 -18yrs with ALT >80

Exclusion Criteria:

• Patients with metabolic disorders,
• On certain medications (i.e., amiodarone, corticosteroids, methotrexate, select antipsychotics /antidepressants, HAART, valproic acid),
• Kwashiorkor
• Alcohol abuse,
• Rapid surgical weight loss,
• History of parenteral nutrition and
• Hepatitis C.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified Time-restricted Feeding	Behavioral: Modified Time-restricted Feeding; The modified time-restricted feeding arm will be asked to consume any food but will be asked to consume this food for only a 9 hour daytime period.; Behavioral: Physical activity; At least 30 minutes of physical activity per day 5 times per week.; Behavioral: Restricted consumption of sweetened beverages; Restricted consumption of juice, soda, and other sweetened beverages.
Active Comparator: Conventional diet	Behavioral: Physical activity; At least 30 minutes of physical activity per day 5 times per week.; Behavioral: Restricted consumption of sweetened beverages; Restricted consumption of juice, soda, and other sweetened beverages.; Behavioral: Conventional diet; The conventional diet arm will be asked to consume a hypocaloric diet, and they will be allowed to eat at any time of the day with no time restriction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Alanine Amino Transferase (ALT) levels	Baseline, 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Body Mass Index (BMI) Z-score	Baseline, 3 months
Change in hepatic steatosis on Magnetic Resonance Elastography of the Liver	Baseline, 3 months
Change in fibrosis on Magnetic Resonance Elastography of the Liver	Baseline, 3 months
Change in diastolic blood pressure	Baseline, 3 months
Change in systolic blood pressure	Baseline, 3 months
Change in LDL	Baseline, 3 months
Change in HDL	Baseline, 3 months
Change in TRIGLYCERIDE	Baseline, 3 months
Change in TOTAL CHOLESTEROL	Baseline, 3 months
Hemoglobin A1C	Baseline; 3 months
Fasting serum insulin	Baseline; 3 months
Fasting serum glucose	Baseline; 3 months

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Essam M Imseis, MD, The University of Texas Health Sciences Center in Houston

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): April 30, 2020
• Study Completion (Anticipated): April 30, 2020

Study Registration Dates

• First Submitted: February 8, 2019
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (Actual): February 20, 2019

Study Record Updates

• Last Update Posted (Actual): March 15, 2019
• Last Update Submitted That Met QC Criteria: March 14, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: HSC-MS-18-1022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No