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

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ClinicalTrials.gov Identifier: NCT03848390
Recruitment Status : Not yet recruiting
First Posted : February 20, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Essam M. Imseis, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Behavioral: Conventional diet Behavioral: Modified Time-restricted Feeding Behavioral: Physical activity Behavioral: Restricted consumption of sweetened beverages Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Modified Time-restricted Feeding in Preventing Progression of Non-Alcoholic Fatty Liver Disease (NAFLD).
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020


Arm Intervention/treatment
Experimental: Modified Time-restricted Feeding 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.

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

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

Active Comparator: Conventional diet Behavioral: 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.

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

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




Primary Outcome Measures :
  1. Change in Alanine Amino Transferase (ALT) levels [ Time Frame: Baseline, 3 months ]

Secondary Outcome Measures :
  1. Change in Body Mass Index (BMI) Z-score [ Time Frame: Baseline, 3 months ]
  2. Change in hepatic steatosis on Magnetic Resonance Elastography of the Liver [ Time Frame: Baseline, 3 months ]
  3. Change in fibrosis on Magnetic Resonance Elastography of the Liver [ Time Frame: Baseline, 3 months ]
  4. Change in diastolic blood pressure [ Time Frame: Baseline, 3 months ]
  5. Change in systolic blood pressure [ Time Frame: Baseline, 3 months ]
  6. Change in LDL [ Time Frame: Baseline, 3 months ]
  7. Change in HDL [ Time Frame: Baseline, 3 months ]
  8. Change in TRIGLYCERIDE [ Time Frame: Baseline, 3 months ]
  9. Change in TOTAL CHOLESTEROL [ Time Frame: Baseline, 3 months ]
  10. Hemoglobin A1C [ Time Frame: Baseline; 3 months ]
  11. Fasting serum insulin [ Time Frame: Baseline; 3 months ]
  12. Fasting serum glucose [ Time Frame: Baseline; 3 months ]


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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848390


Contacts
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Contact: Essam M Imseis, MD 713-500-5663 essam.imseis@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Not yet recruiting
Houston, Texas, United States, 77030
Contact: Essam M Imseis, MD    713-500-5663    essam.imseis@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Essam M Imseis, MD The University of Texas Health Sciences Center in Houston

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Responsible Party: Essam M. Imseis, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03848390     History of Changes
Other Study ID Numbers: HSC-MS-18-1022
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases