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

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ClinicalTrials.gov Identifier: NCT02787668
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Amy Miskimon Goss, PhD RD, University of Alabama at Birmingham

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).

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Childhood Obesity Insulin Resistance Other: Carbohydrate-restricted diet Other: Control, low-fat diet Not Applicable

Detailed Description:
NAFLD is the most common form of liver disease in children in the United States. Currently, there is no treatment for NAFLD. In adults, weight loss through caloric restriction is commonly recommended to improve fatty liver. Weight loss is particularly difficult for children to achieve and significant caloric restriction may not be a prudent recommendation in developing children and adolescents. Because of this difficulty with weight loss in children, many children go on to develop cirrhosis and eventually undergo liver transplant. Data on the effectiveness of diet to reverse fatty liver and prevent progression to cirrhosis in children is urgently needed. To date, no studies have been done examining how changes in diet composition without intentional caloric restriction influences NAFLD in children. Data from previous studies in adults support the hypothesis that consumption of lower-CHO, higher-fat food sources rich in high-quality proteins and essential fatty acids has beneficial effects on metabolic health in adults without restricting calories. This study aims to test the hypothesis that a low CHO higher- fat diet will induce rapid reversal of fatty liver while also depleting of total and abdominal adiposity, preserving lean mass, and reducing inflammation in adolescents with obesity and NAFLD.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Carbohydrate-restricted Diet to Reverse Fatty Liver in Adolescents With Obesity
Actual Study Start Date : May 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018


Arm Intervention/treatment
Experimental: Carbohydrate-restricted diet
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. During the first two weeks of the intervention,
Other: Carbohydrate-restricted diet
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.

Active Comparator: Control, low-fat diet
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
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.




Primary Outcome Measures :
  1. Change in hepatic lipid assessed via magnetic resonance imaging (MRI and magnetic resonance spectroscopy (MRS). [ Time Frame: 8 weeks after baseline ]

Secondary Outcome Measures :
  1. Change in body composition via dual-energy X-ray absorptiometry (DXA). [ Time Frame: 8 weeks after baseline ]
  2. Change in liver enzymes via fasting blood draw [ Time Frame: At baseline and weeks 2, 4, and 8. ]
  3. Change in fasting glucose via blood draw [ Time Frame: At baseline and weeks 2, 4, and 8. ]
  4. Change in fasting insulin via blood draw [ Time Frame: At baseline and weeks 2, 4, and 8. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 counselling sessions with the registered dietitian during week 2, 4 and 6 of the diet intervention.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787668


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35223
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Amy M Goss, PhD University of Alabama at Birmingham
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amy Miskimon Goss, PhD RD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02787668    
Other Study ID Numbers: F160218006
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Amy Miskimon Goss, PhD RD, University of Alabama at Birmingham:
childhood obesity
Non-alcoholic fatty liver disease
insulin resistance
carbohydrate-restriction
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Obesity
Insulin Resistance
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Digestive System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases