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

The University of Texas Health Science Center, Houston1 site in 1 country40 target enrollmentApril 1, 2019

ConditionsNon-Alcoholic Fatty Liver Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Non-Alcoholic Fatty Liver Disease
Sponsor: The University of Texas Health Science Center, Houston
Enrollment: 40
Locations: 1
Primary Endpoint: Change in Alanine Amino Transferase (ALT) levels
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 1, 2019

End Date

April 30, 2020

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The University of Texas Health Science Center, Houston

Responsible Party

Principal Investigator

Essam M. Imseis

Associate Professor

The University of Texas Health Science Center, Houston

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in Alanine Amino Transferase (ALT) levels

Time Frame: Baseline, 3 months

Secondary Outcomes

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 LDL(Baseline, 3 months)
Change in TOTAL CHOLESTEROL(Baseline, 3 months)
Fasting serum insulin(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 HDL(Baseline, 3 months)
Change in TRIGLYCERIDE(Baseline, 3 months)
Hemoglobin A1C(Baseline; 3 months)
Fasting serum glucose(Baseline; 3 months)