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

The University of Texas System (UT)

Status: Unknown

Conditions: Non-Alcoholic Fatty Liver Disease

Treatments: Behavioral: Modified Time-restricted Feeding; Behavioral: Conventional diet; Behavioral: Physical activity; Behavioral: Restricted consumption of sweetened beverages

Study type: Interventional

Funder types: Other

Identifiers

NCT03848390

HSC-MS-18-1022

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Modified Time-restricted Feeding

Experimental group

Treatment:

Behavioral: Modified Time-restricted Feeding

Behavioral: Restricted consumption of sweetened beverages

Behavioral: Physical activity

Conventional diet

Active Comparator group

Treatment:

Behavioral: Conventional diet

Behavioral: Restricted consumption of sweetened beverages

Behavioral: Physical activity