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

Not Applicable

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

• Registration Number: NCT03848390
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-08
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-20
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-14
• Last Update Posted: 2019-03-15
• Study Start: 2019-04-01
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified Time-restricted Feeding	Physical activity	-
Modified Time-restricted Feeding	Modified Time-restricted Feeding	-
Modified Time-restricted Feeding	Restricted consumption of sweetened beverages	-
Conventional diet	Restricted consumption of sweetened beverages	-
Conventional diet	Conventional diet	-
Conventional diet	Physical activity	-

Primary Outcome Measures

Name	Time	Method
Change in Alanine Amino Transferase (ALT) levels	Baseline, 3 months

Secondary Outcome Measures

Name	Time	Method
Fasting serum insulin	Baseline; 3 months
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
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

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States