Non-Alcoholic Fatty Liver DiseaseNCT03848390
Effect of Modified Time-restricted Feeding in Preventing Progression of Non-Alcoholic Fatty Liver Disease (NAFLD).
A study testing Conventional diet, Modified Time-restricted Feeding and Physical activity in people with Non-Alcoholic Fatty Liver Disease, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Conventional diet, Modified Time-restricted Feeding and Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Motivated obese fatty liver patients aged 8 -18yrs with ALT >80
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Essam M Imseis, MD, 713-500-5663, essam.imseis@uth.tmc.edu
About this study
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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Conventional diet, Modified Time-restricted Feeding, Physical activity, Restricted consumption of sweetened beverages
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional dietBehavioural
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.
Modified Time-restricted FeedingBehavioural
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 activityBehavioural
At least 30 minutes of physical activity per day 5 times per week.
Restricted consumption of sweetened beveragesBehavioural
Restricted consumption of juice, soda, and other sweetened beverages.
| Study group | Role | What they receive |
|---|---|---|
| Modified Time-restricted Feeding | Experimental | Not described Receives: Behavioral: Modified Time-restricted Feeding; Behavioral: Physical activity; Behavioral: Restricted consumption of sweetened beverages |
| Conventional diet | Active comparator | Not described Receives: Behavioral: Conventional diet; Behavioral: Physical activity; Behavioral: Restricted consumption of sweetened beverages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alanine Amino Transferase (ALT) levels
Measured: Baseline, 3 months
Secondary outcomes (12)
Change in Body Mass Index (BMI) Z-score
Measured: Baseline, 3 months
Change in hepatic steatosis on Magnetic Resonance Elastography of the Liver
Measured: Baseline, 3 months
Change in fibrosis on Magnetic Resonance Elastography of the Liver
Measured: Baseline, 3 months
Change in diastolic blood pressure
Measured: Baseline, 3 months
Change in systolic blood pressure
Measured: Baseline, 3 months
Change in LDL
Measured: Baseline, 3 months
Change in HDL
Measured: Baseline, 3 months
Change in TRIGLYCERIDE
Measured: Baseline, 3 months
Change in TOTAL CHOLESTEROL
Measured: Baseline, 3 months
Hemoglobin A1C
Measured: Baseline; 3 months
Fasting serum insulin
Measured: Baseline; 3 months
Fasting serum glucose
Measured: Baseline; 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start1 Apr 2019 (estimated)
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Essam M. Imseis, The University of Texas Health Science Center, Houston
- Investigators
- Essam M Imseis, MD, Principal investigator, The University of Texas Health Sciences Center in Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848390
- Sponsor's protocol ID
- HSC-MS-18-1022
- Status last verified
- Mar 2019
- First submitted
- 8 Feb 2019
- Last updated
- 15 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Modified Time-restricted Feeding in Preventing Progression of Non-Alcoholic Fatty Liver Disease (NAFLD).
- ClinicalTrials.gov ID
- NCT03848390
- Acronym / sponsor ID
- HSC-MS-18-1022
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Motivated obese fatty liver patients aged 8 -18yrs with ALT >80
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional dietThe 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. | Behavioural | Conventional diet |
| Modified Time-restricted FeedingThe 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. | Behavioural | Modified Time-restricted Feeding |
| Physical activityAt least 30 minutes of physical activity per day 5 times per week. | Behavioural | Conventional diet, Modified Time-restricted Feeding |
| Restricted consumption of sweetened beveragesRestricted consumption of juice, soda, and other sweetened beverages. | Behavioural | Conventional diet, Modified Time-restricted Feeding |
Primary outcome
Change in Alanine Amino Transferase (ALT) levels
Time frame: Baseline, 3 months
12 secondary outcomes
Change in Body Mass Index (BMI) Z-score
Time frame: Baseline, 3 months
Change in hepatic steatosis on Magnetic Resonance Elastography of the Liver
Time frame: Baseline, 3 months
Change in fibrosis on Magnetic Resonance Elastography of the Liver
Time frame: Baseline, 3 months
Change in diastolic blood pressure
Time frame: Baseline, 3 months
Change in systolic blood pressure
Time frame: Baseline, 3 months
Change in LDL
Time frame: Baseline, 3 months
Change in HDL
Time frame: Baseline, 3 months
Change in TRIGLYCERIDE
Time frame: Baseline, 3 months
Change in TOTAL CHOLESTEROL
Time frame: Baseline, 3 months
Hemoglobin A1C
Time frame: Baseline; 3 months
Fasting serum insulin
Time frame: Baseline; 3 months
Fasting serum glucose
Time frame: Baseline; 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Essam M Imseis, MD principal investigator
The University of Texas Health Sciences Center in Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional diet, Modified Time-restricted Feeding and Physical activity in people with Non-Alcoholic Fatty Liver Disease, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Essam M Imseis, MD (713-500-5663, essam.imseis@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alanine Amino Transferase (ALT) levels (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019.