Effect of Modified Time-restricted Feeding in Preventing... | NCT03848390

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

NCT03848390

Sponsor

The University of Texas Health Science Center, Houston

Status

Unknown status

Last Update Posted

Mar 15, 2019Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Non-Alcoholic Fatty Liver Disease

Interventions

Conventional diet
Modified Time-restricted Feeding
Physical activity
Restricted consumption of sweetened beverages

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2019Estimated

Primary Completion Date

Apr 30, 2020Estimated

Completion Date

Apr 30, 2020Estimated

First Submitted Date

Feb 8, 2019

First Submission Date that Met QC Criteria

Feb 19, 2019

First Posted Date

Feb 20, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2019

Last Update Posted Date

Mar 15, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Essam M. Imseis, Associate Professor, The University of Texas Health Science Center, HoustonPrincipal Investigator

Lead Sponsor

The University of Texas Health Science Center, HoustonOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Modified Time-restricted Feeding	Experimental		Behavioral: Modified Time-restricted Feeding Behavioral: Physical activity Behavioral: Restricted consumption of sweetened beverages
Conventional diet	Active Comparator		Behavioral: Conventional diet Behavioral: Physical activity Behavioral: Restricted consumption of sweetened beverages

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Conventional diet	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Alanine Amino Transferase (ALT) levels		Baseline, 3 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Essam M Imseis, MD	Contact	713-500-5663		essam.imseis@uth.tmc.edu

Overall Officials

Name	Affiliation	Role
Essam M Imseis, MD	The University of Texas Health Sciences Center in Houston	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Texas Health Science Center at Houston		Houston	Texas	77030	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena