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

Primary Purpose

Non-Alcoholic Fatty Liver Disease

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conventional diet
Modified Time-restricted Feeding
Physical activity
Restricted consumption of sweetened beverages
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Modified Time-restricted Feeding

Conventional diet

Arm Description

Outcomes

Primary Outcome Measures

Change in Alanine Amino Transferase (ALT) levels

Secondary Outcome Measures

Change in Body Mass Index (BMI) Z-score
Change in hepatic steatosis on Magnetic Resonance Elastography of the Liver
Change in fibrosis on Magnetic Resonance Elastography of the Liver
Change in diastolic blood pressure
Change in systolic blood pressure
Change in LDL
Change in HDL
Change in TRIGLYCERIDE
Change in TOTAL CHOLESTEROL
Hemoglobin A1C
Fasting serum insulin
Fasting serum glucose

Full Information

First Posted
February 8, 2019
Last Updated
March 14, 2019
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT03848390
Brief Title
Effect of Modified Time-restricted Feeding in Preventing Progression of Non-Alcoholic Fatty Liver Disease (NAFLD).
Official Title
Effect of Modified Time-restricted Feeding in Preventing Progression of Non-Alcoholic Fatty Liver Disease (NAFLD).
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Anticipated)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
April 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Modified Time-restricted Feeding
Arm Type
Experimental
Arm Title
Conventional diet
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Conventional diet
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Modified Time-restricted Feeding
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Intervention Description
At least 30 minutes of physical activity per day 5 times per week.
Intervention Type
Behavioral
Intervention Name(s)
Restricted consumption of sweetened beverages
Intervention Description
Restricted consumption of juice, soda, and other sweetened beverages.
Primary Outcome Measure Information:
Title
Change in Alanine Amino Transferase (ALT) levels
Time Frame
Baseline, 3 months
Secondary Outcome Measure Information:
Title
Change in Body Mass Index (BMI) Z-score
Time Frame
Baseline, 3 months
Title
Change in hepatic steatosis on Magnetic Resonance Elastography of the Liver
Time Frame
Baseline, 3 months
Title
Change in fibrosis on Magnetic Resonance Elastography of the Liver
Time Frame
Baseline, 3 months
Title
Change in diastolic blood pressure
Time Frame
Baseline, 3 months
Title
Change in systolic blood pressure
Time Frame
Baseline, 3 months
Title
Change in LDL
Time Frame
Baseline, 3 months
Title
Change in HDL
Time Frame
Baseline, 3 months
Title
Change in TRIGLYCERIDE
Time Frame
Baseline, 3 months
Title
Change in TOTAL CHOLESTEROL
Time Frame
Baseline, 3 months
Title
Hemoglobin A1C
Time Frame
Baseline; 3 months
Title
Fasting serum insulin
Time Frame
Baseline; 3 months
Title
Fasting serum glucose
Time Frame
Baseline; 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Essam M Imseis, MD
Phone
713-500-5663
Email
essam.imseis@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Essam M Imseis, MD
Organizational Affiliation
The University of Texas Health Sciences Center in Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Essam M Imseis, MD
Phone
713-500-5663
Email
essam.imseis@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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