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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

Must not have

Autoimmune liver disease

History of bariatric surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an autoimmune liver condition.

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I have had weight loss surgery in the past.

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I have Wilson's disease.

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I have a liver condition that affects how my body uses and stores energy.

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I am currently undergoing a strict lifestyle change program.

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I have been on IV nutrition in the past.

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I have a genetic condition causing fatty liver.

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I haven't taken drugs that affect liver fat, enzymes, weight, or sugar levels in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hepatic lipid

Secondary study objectives

Body composition

Hepatic insulin sensitivity

Plasma metabolome

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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).

0 / 10Eligibility criteria met