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Carbohydrate-Restricted Diet for Non-alcoholic Fatty Liver Disease

N/A
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 10-17 years
Clinical-pathological diagnosis of NAFLD and current evidence of active disease, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial will test whether a moderately carbohydrate-restricted diet can improve Nonalcoholic Fatty Liver Disease (NAFLD) in children and adolescents.

Who is the study for?
This trial is for children and adolescents aged 10-17 with Non-alcoholic Fatty Liver Disease (NAFLD) who are overweight or obese. They must have evidence of fatty liver via ultrasound, elevated ALT levels, and an HbA1c below 7%. Participants should not be on certain medications affecting the liver, be pregnant, or have other specific liver diseases.Check my eligibility
What is being tested?
The study compares a moderately carbohydrate-restricted diet to a fat-restricted diet over six months. It includes a controlled feeding phase where food is provided for 12 weeks followed by a 'free living' phase. Physical activity will be monitored using smart watches.See study design
What are the potential side effects?
Potential side effects may include changes in blood sugar levels, digestive discomfort from dietary adjustments, and possible nutrient deficiencies due to restricted diets. Close monitoring will help manage any adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 10 and 17 years old.
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I have been diagnosed with fatty liver disease and my liver tests are high.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hepatic lipid
Secondary outcome measures
Body composition
Hepatic insulin sensitivity
Plasma metabolome

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Moderately carbohydrate-restricted dietExperimental Treatment1 Intervention
For this study, the investigators will use the low glycemic, moderately carbohydrate-restricted diet that the investigators have previously shown is associated with depletion of hepatic lipid content, and improvement in insulin resistance in adolescents with NAFLD. This diet has a macronutrient composition of approximately 25% energy from carbohydrate, 20% energy from protein, and 55% energy from fat. No food group is excluded in this diet prescription; however, the diet emphasizes low-glycemic sources of carbohydrate, and includes mainly whole foods (vegetables, fruits, whole grains) with minimal highly processed grain products and added sugar. Protein foods will include meat, poultry, fish, eggs, and whey protein supplements if necessary. Fat-containing foods will include olive, coconut, and nut oils; butter; tree nuts and nut butters; cheese; cream; coconut milk; avocados; and the fat found in meat. A number of full-fat dairy products will be included.
Group II: Fat-restricted dietActive Control1 Intervention
The fat-restricted, control diet will consist of approximately 60% carbohydrate, 20% protein, 20% fat. Participants will be given low-fat foods, whole-grain foods, fruits, and vegetables. The meal plans will minimize cholesterol, high-fat foods, high-cholesterol foods, processed starches, and added sugar, and will provide <2300 mg/day sodium. Saturated fat will be limited to 10% of total fat intake, and all dairy products will be fat-free (or low fat).

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,254 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
120 Patients Enrolled for Non-alcoholic Fatty Liver Disease
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,511 Total Patients Enrolled
46 Trials studying Non-alcoholic Fatty Liver Disease
9,892 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

Non-alcoholic Fatty Liver Disease Research Study Groups: Moderately carbohydrate-restricted diet, Fat-restricted diet
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Moderately carbohydrate-restricted diet Highlights & Side Effects. Trial Name: NCT05268042 — N/A
Moderately carbohydrate-restricted diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT05268042 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are involved in this exploration?

"Affirmative. Clinicaltrials.gov's records show that this investigation, which was initially put up on May 1st 2022, is actively looking for participants. 80 volunteers must be admitted from one medical facility."

Answered by AI

Has the enrollment period for this research opened yet?

"Reports from clinicaltrials.gov state that this experiment is in pursuit of participants. Initially posted on May 1st 2022, the trial was most recently edited on May 9th 2022."

Answered by AI

Is the age requirement for participants in this trial restricted to those over 18?

"This trial is open to minors aged between 12 and 17 years old."

Answered by AI

Could I be eligible to partake in this trial?

"This clinical trial has a maximum age requirement of 17 and requires that participants have obesity. It is currently recruiting 80 individuals to participate."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
What site did they apply to?
University of Alabama at Birmingham
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Moderately Carbohydrate-restricted Diet to Treat NAFLD in Adolescents
Amy Miskimon Goss 2022. "Moderately Carbohydrate-restricted Diet to Treat NAFLD in Adolescents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05268042.
All > Nafld
~33 spots leftby Aug 2025
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