A Carbohydrate-restricted Diet to Reverse Fatty Liver in Adolescents With Obesity

NCT02787668 | Completed DMC

• 1 other identifier: F160218006
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effects of a low carbohydrate diet vs a low fat diet on improvement in aminotransferases, hepatic fat infiltration, markers of inflammation, insulin resistance, and body composition in obese adolescents with non-alcoholic fatty liver disease (NAFLD).

Conditions

Non-alcoholic Fatty Liver Disease; Childhood Obesity; Insulin Resistance

Keywords

childhood obesity; Non-alcoholic fatty liver disease; insulin resistance; carbohydrate-restriction

Outcome Measures

Primary Outcomes (1)

• Change in hepatic lipid assessed via magnetic resonance imaging (MRI and magnetic resonance spectroscopy (MRS).

  8 weeks after baseline

Secondary Outcomes (4)

• Change in body composition via dual-energy X-ray absorptiometry (DXA).

  8 weeks after baseline

• Change in liver enzymes via fasting blood draw

  At baseline and weeks 2, 4, and 8.

• Change in fasting glucose via blood draw

  At baseline and weeks 2, 4, and 8.

• Change in fasting insulin via blood draw

  At baseline and weeks 2, 4, and 8.

Study Arms (2)

Carbohydrate-restricted diet

EXPERIMENTAL

This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose and will provide ≤10% energy from CHO, 25% energy from protein, and ≥65% energy from fat.

Other: Carbohydrate-restricted diet

Control, low-fat diet

ACTIVE COMPARATOR

The control, low-fat diet will contain 55:25:20 %energy from CHO:protein:fat based on the USDA MyPlate Daily Food Plan. For example, an 1800kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.

Other: Control, low-fat diet

Interventions

Carbohydrate-restricted diet OTHER

Participants will be randomized (20 per group) to the carbohydrate restricted diet (i.e., CHO \<10%; fat \>65%, protein 25%) or a low fat diet (CHO 55%; fat 20%; protein 25%) for 8 weeks. Individual counseling with the study physician and registered dietitian (RD) will be provided at baseline for initial assessment and diet instruction. Participants will meet with a RD for an individual counselling session at week 2, 4, and 6 of the diet intervention to ensure adherence to the diet prescription. Participants will be encouraged to keep track of dietary intake by using electronic food diaries (weeks 1-8) to review with the RD during individual counseling at week 2, week 4 and week 6.

Carbohydrate-restricted diet

Control, low-fat diet OTHER

Individual counseling with the study physician and registered dietitian (RD) will be provided at baseline for initial assessment and diet instruction. Participants will meet with a RD for an individual counselling session at week 2, 4, and 6 of the diet intervention to ensure adherence to the diet prescription. Participants will be encouraged to keep track of dietary intake by using electronic food diaries (weeks 1-8) to review with the RD during individual counseling at week 2, week 4 and week 6.

Control, low-fat diet

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Overweight/obese (BMI over the 85th percentile) male and female adolescents (age range 10-17) with elevated serum aminotransferase levels, diffusely echogenic liver via ultrasound suggestive of fatty liver, and/or prior diagnosis of NAFLD. Participant eligibility will depend on the ability of one parent to attend the initial diet instruction and individual counseling sessions with the registered dietitian during week 2, 4 and 6 of the diet intervention.

You may not qualify if:

• Presence of hepatic virus infections (HCV RNA-polymerase chain reaction negative; hepatitis A, B, C, D, E, and G; cytomegalovirus; and Epstein-Barr virus), alcohol consumption, history of parenteral nutrition, and use of drugs known to induce steatosis (for example, valproate, amiodarone, or prednisone) or to affect body weight and carbohydrate metabolism. Autoimmune liver disease, metabolic liver disease, and Wilson's disease will be ruled out by the participants physician prior to enrollment in the study.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35223, United States

Location

Related Publications (1)

• Dowla S, Pendergrass M, Bolding M, Gower B, Fontaine K, Ashraf A, Soleymani T, Morrison S, Goss A. Effectiveness of a carbohydrate restricted diet to treat non-alcoholic fatty liver disease in adolescents with obesity: Trial design and methodology. Contemp Clin Trials. 2018 May;68:95-101. doi: 10.1016/j.cct.2018.03.014. Epub 2018 Mar 27.

  PMID: 29601997 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Pediatric Obesity; Insulin Resistance

Interventions

Diet, Carbohydrate-Restricted; Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Amy M Goss, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 1, 2016
• Study Start: May 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: February 21, 2022

Record last verified: 2022-02

Locations

US (1)