Effect of Modified Time-restricted Feeding in Preventing Progression of Non-Alcoholic Fatty Liver Disease (NAFLD).
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2019
CompletedFirst Posted
Study publicly available on registry
February 20, 2019
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedMarch 15, 2019
March 1, 2019
1.1 years
February 8, 2019
March 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Alanine Amino Transferase (ALT) levels
Baseline, 3 months
Secondary Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (2)
Modified Time-restricted Feeding
EXPERIMENTALConventional diet
ACTIVE COMPARATORInterventions
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.
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.
At least 30 minutes of physical activity per day 5 times per week.
Restricted consumption of juice, soda, and other sweetened beverages.
Eligibility Criteria
You may qualify if:
- Motivated obese fatty liver patients aged 8 -18yrs with ALT \>80
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Essam M Imseis, MD
The University of Texas Health Sciences Center in Houston
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 8, 2019
First Posted
February 20, 2019
Study Start
April 1, 2019
Primary Completion
April 30, 2020
Study Completion
April 30, 2020
Last Updated
March 15, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share