Non-Alcoholic Fatty Liver Disease
Conditions
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.
Interventions
BEHAVIORALConventional 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.
BEHAVIORALModified 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.
BEHAVIORALPhysical activity
At least 30 minutes of physical activity per day 5 times per week.
BEHAVIORALRestricted consumption of sweetened beverages
Restricted consumption of juice, soda, and other sweetened beverages.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Alanine Amino Transferase (ALT) levels | Baseline, 3 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 Body Mass Index (BMI) Z-score | 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 |
| Change in HDL | Baseline, 3 months |
Countries
United States
Contacts
Primary ContactEssam M Imseis, MD
Outcome results
None listed