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NCT05268042 · ClinicalTrials.gov registry record · NA
Moderately Carbohydrate-restricted Diet to Treat NAFLD in Adolescents
A NA study of Obesity and Non-alcoholic Fatty Liver Disease, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT05268042: Recruiting NA study of Obesity and Non-alcoholic Fatty Liver Disease, sponsored by University of Alabama at Birmingham.
NCT05268042 is a NA study of Obesity and Non-alcoholic Fatty Liver Disease that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 80 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05268042, a NA study of Obesity and Non-alcoholic Fatty Liver Disease, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
This will be a 6-month randomized clinical trial with two arms: moderately carbohydrate-restricted diet and a fat-restricted control diet. This 6-month study will have 2 phases: a 12-week controlled feeding phase and a 12-week "free living" phase. During the controlled feeding phase, all food will be provided to the families of the participants for the entirety of the 12 weeks. Participants (n=80) will have been diagnosed with NAFLD based on the presence of current evidence of active disease, which will be determined by the ongoing presence of hepatic steatosis estimated by diffusely echogenic liver via ultrasound suggestive of fatty liver and a serum alanine aminotransferase (ALT) level of 45 U/L or greater. All participants will be children and adolescents age 10-17 yrs.; will have an HbA1c \<7.0; and will be overweight or obese (BMI \>85th percentile). It is anticipated that most participants will be sedentary. The investigators will inquire as to routine physical activity at screening. All participants will be asked to maintain their usual level of physical activity throughout the study. Physical activity will be monitored via a smart watch provided to each participant at the beginning of the study, and participants will be queried weekly by the study dietitian regarding changes in physical activity. Participants who use oral contraceptives will be asked to maintain consistent use of these preparations throughout the study. Hormone use will be examined as a potential covariate in statistical analyses.
Primary Outcome
Hepatic lipid will be measured using MRI and Magnetic resonance spectroscopy (MRS).
Conditions Studied
Interventions
- OTHER Moderately carbohydrate-restricted diet
- OTHER Fat-restricted diet
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2022-05-01 |
| Est. Completion | 2026-05-01 |
| Phase | NA |
What NCT05268042 shows while recruiting
NCT05268042 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Moderately carbohydrate-restricted diet is the first listed.
NCT05268042 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT05268042 about?
NCT05268042 is a clinical study titled "Moderately Carbohydrate-restricted Diet to Treat NAFLD in Adolescents". This will be a 6-month randomized clinical trial with two arms: moderately carbohydrate-restricted diet and a fat-restricted control diet. This 6-month study will have 2 phases: a 12-week controlled feeding phase and a 12-week "free living" phase. During the controlled feeding phase, all food will b...
What is the current status of trial NCT05268042?
This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2022-05-01. Estimated completion is 2026-05-01.
What conditions does trial NCT05268042 study?
This clinical trial studies the following conditions: Obesity, Non-alcoholic Fatty Liver Disease.
What interventions are being tested in trial NCT05268042?
The interventions under investigation include: Moderately carbohydrate-restricted diet (OTHER), Fat-restricted diet (OTHER).
Who is sponsoring clinical trial NCT05268042?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05268042 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05268042's enrollment target sits among peer trials
80 546th of 1053 higher than 498 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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