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

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03848390
• Other study ID #: HSC-MS-18-1022
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: March 2019
• Source: The University of Texas Health Science Center, Houston
• Contact: Essam M Imseis, MD
• Phone: 713-500-5663
• Email: essam.imseis[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

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.
• 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.
• Physical activity
At least 30 minutes of physical activity per day 5 times per week.
• Restricted consumption of sweetened beverages
Restricted consumption of juice, soda, and other sweetened beverages.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Alanine Amino Transferase (ALT) levels		Baseline, 3 months
Secondary	Change in Body Mass Index (BMI) Z-score		Baseline, 3 months
Secondary	Change in hepatic steatosis on Magnetic Resonance Elastography of the Liver		Baseline, 3 months
Secondary	Change in fibrosis on Magnetic Resonance Elastography of the Liver		Baseline, 3 months
Secondary	Change in diastolic blood pressure		Baseline, 3 months
Secondary	Change in systolic blood pressure		Baseline, 3 months
Secondary	Change in LDL		Baseline, 3 months
Secondary	Change in HDL		Baseline, 3 months
Secondary	Change in TRIGLYCERIDE		Baseline, 3 months
Secondary	Change in TOTAL CHOLESTEROL		Baseline, 3 months
Secondary	Hemoglobin A1C		Baseline; 3 months
Secondary	Fasting serum insulin		Baseline; 3 months
Secondary	Fasting serum glucose		Baseline; 3 months