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

Study Overview
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Brief Summary
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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.

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

Conditions
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Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
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* Behavioral: Conventional diet
* Behavioral: Modified Time-restricted Feeding
* Behavioral: Physical activity
* Behavioral: Restricted consumption of sweetened beverages


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified Time-restricted Feeding<br> | Behavioral: Modified Time-restricted Feeding<br>* 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.<br>Behavioral: Physical activity<br>* At least 30 minutes of physical activity per day 5 times per week.<br>Behavioral: Restricted consumption of sweetened beverages<br>* Restricted consumption of juice, soda, and other sweetened beverages.<br>|
| Active Comparator: Conventional diet<br> | Behavioral: Conventional diet<br>* 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.<br>Behavioral: Physical activity<br>* At least 30 minutes of physical activity per day 5 times per week.<br>Behavioral: Restricted consumption of sweetened beverages<br>* Restricted consumption of juice, soda, and other sweetened beverages.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |