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

NCT ID: NCT03848390

Last Updated: 2019-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-04-30

Brief Summary

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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

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Conditions

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Non-Alcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Modified Time-restricted Feeding

Group Type EXPERIMENTAL

Modified Time-restricted Feeding

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

At least 30 minutes of physical activity per day 5 times per week.

Restricted consumption of sweetened beverages

Intervention Type BEHAVIORAL

Restricted consumption of juice, soda, and other sweetened beverages.

Conventional diet

Group Type ACTIVE_COMPARATOR

Conventional diet

Intervention Type 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.

Physical activity

Intervention Type BEHAVIORAL

At least 30 minutes of physical activity per day 5 times per week.

Restricted consumption of sweetened beverages

Intervention Type BEHAVIORAL

Restricted consumption of juice, soda, and other sweetened beverages.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Physical activity

At least 30 minutes of physical activity per day 5 times per week.

Intervention Type BEHAVIORAL

Restricted consumption of sweetened beverages

Restricted consumption of juice, soda, and other sweetened beverages.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Essam M. Imseis

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Essam M Imseis, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Sciences Center in Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Essam M Imseis, MD

Role: CONTACT

713-500-5663

Facility Contacts

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Essam M Imseis, MD

Role: primary

713-500-5663

Other Identifiers

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HSC-MS-18-1022

Identifier Type: -

Identifier Source: org_study_id

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