PMID- 29601997
OWN - NLM
STAT- MEDLINE
DCOM- 20191017
LR  - 20200306
IS  - 1559-2030 (Electronic)
IS  - 1551-7144 (Print)
IS  - 1551-7144 (Linking)
VI  - 68
DP  - 2018 May
TI  - Effectiveness of a carbohydrate restricted diet to treat non-alcoholic fatty 
      liver disease in adolescents with obesity: Trial design and methodology.
PG  - 95-101
LID - S1551-7144(17)30601-8 [pii]
LID - 10.1016/j.cct.2018.03.014 [doi]
AB  - BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is the most common liver 
      disorder among children in the developed world and can progress to cirrhosis, 
      hepatocellular carcinoma, and liver failure. No evidence-based dietary guidelines 
      exist on the most effective diet prescription to treat NAFLD. OBJECTIVE: To 
      compare the effect of a carbohydrate (CHO)-restricted diet vs fat-restricted 
      diet, the current standard of care, on changes in hepatic fat infiltration, body 
      composition, and metabolic health over an 8-week period among overweight and 
      obese children diagnosed with NAFLD. METHODS: In this two-arm, parallel design 
      randomized controlled trial (RCT), 40 participants aged 9 to 18 years were 
      randomized to a CHO restricted diet (<25:>50:25% daily calories from CHO: fat: 
      protein) or control, fat restricted diet (55,20:25% daily calories from CHO: fat: 
      protein). This family-based diet intervention included: (1) a 2-week supply of 
      groceries to feed a four-person household specific to the assigned diet; and (2) 
      extensive education on diet implementation through biweekly, diet-specific group 
      and individualized counseling sessions with participants and one parent or 
      guardian led by a registered dietitian (RD). The primary outcome measure of this 
      study was hepatic lipid, measured using magnetic resonance spectroscopy (MRS). 
      Secondary outcomes included liver transaminases; markers of inflammation (hsCRP, 
      IL-6, TNF-alpha); body composition; visceral adipose tissue; and insulin resistance. 
      All testing was conducted at baseline and week 8; hepatic transaminases were also 
      measured at weeks 2 and 4. This RCT is registered with ClinicalTrials.gov (ID: 
      NCT02787668).
CI  - Copyright (c) 2018 Elsevier Inc. All rights reserved.
FAU - Dowla, Shima
AU  - Dowla S
AD  - Department of Health Behavior, University of Alabama at Birmingham, Birmingham, 
      AL, United States; School of Medicine, University of Alabama at Birmingham, 
      Birmingham, AL, United States.
FAU - Pendergrass, May
AU  - Pendergrass M
AD  - Department of Nutrition, University of Alabama at Birmingham, Birmingham, AL, 
      United States.
FAU - Bolding, Mark
AU  - Bolding M
AD  - Division of Advanced Medical Imaging Research, Department of Radiology, 
      University of Alabama at Birmingham, Birmingham, AL, United States.
FAU - Gower, Barbara
AU  - Gower B
AD  - Department of Nutrition, University of Alabama at Birmingham, Birmingham, AL, 
      United States.
FAU - Fontaine, Kevin
AU  - Fontaine K
AD  - Department of Health Behavior, University of Alabama at Birmingham, Birmingham, 
      AL, United States.
FAU - Ashraf, Ambika
AU  - Ashraf A
AD  - Division of Pediatric Endocrinology, Department of Pediatrics, University of 
      Alabama at Birmingham, Birmingham, AL, United States.
FAU - Soleymani, Taraneh
AU  - Soleymani T
AD  - Department of Nutrition, University of Alabama at Birmingham, Birmingham, AL, 
      United States.
FAU - Morrison, Shannon
AU  - Morrison S
AD  - School of Nursing, University of Alabama at Birmingham, Birmingham, AL, United 
      States.
FAU - Goss, Amy
AU  - Goss A
AD  - Department of Nutrition, University of Alabama at Birmingham, Birmingham, AL, 
      United States. Electronic address: amymiski@uab.edu.
LA  - eng
SI  - ClinicalTrials.gov/NCT02787668
GR  - TL1 TR001418/TR/NCATS NIH HHS/United States
GR  - P30 DK079626/DK/NIDDK NIH HHS/United States
GR  - P60 DK079626/DK/NIDDK NIH HHS/United States
GR  - M01 RR000032/RR/NCRR NIH HHS/United States
GR  - P30 DK056336/DK/NIDDK NIH HHS/United States
GR  - T32 GM008361/GM/NIGMS NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20180327
PL  - United States
TA  - Contemp Clin Trials
JT  - Contemporary clinical trials
JID - 101242342
SB  - IM
MH  - Adolescent
MH  - Body Composition
MH  - Body Mass Index
MH  - Child
MH  - Diet Therapy/methods
MH  - Diet, Carbohydrate-Restricted/*methods
MH  - Diet, Fat-Restricted/*methods
MH  - Directive Counseling/methods
MH  - Female
MH  - Humans
MH  - Intra-Abdominal Fat/diagnostic imaging
MH  - *Liver/diagnostic imaging/pathology
MH  - Liver Function Tests/methods
MH  - Magnetic Resonance Spectroscopy/methods
MH  - Male
MH  - *Non-alcoholic Fatty Liver Disease/diagnosis/diet therapy/etiology/pathology
MH  - *Obesity/complications/diagnosis
MH  - Outcome Assessment, Health Care
MH  - Patient Education as Topic
PMC - PMC6411075
MID - NIHMS957665
OTO - NOTNLM
OT  - Adolescent
OT  - Carbohydrate restriction
OT  - Childhood obesity
OT  - Diet intervention
OT  - Non-alcoholic fatty liver disease
COIS- Conflicts of Interest: None
EDAT- 2018/03/31 06:00
MHDA- 2019/10/18 06:00
PMCR- 2019/05/01
CRDT- 2018/03/31 06:00
PHST- 2017/09/21 00:00 [received]
PHST- 2018/03/20 00:00 [revised]
PHST- 2018/03/22 00:00 [accepted]
PHST- 2018/03/31 06:00 [pubmed]
PHST- 2019/10/18 06:00 [medline]
PHST- 2018/03/31 06:00 [entrez]
PHST- 2019/05/01 00:00 [pmc-release]
AID - S1551-7144(17)30601-8 [pii]
AID - 10.1016/j.cct.2018.03.014 [doi]
PST - ppublish
SO  - Contemp Clin Trials. 2018 May;68:95-101. doi: 10.1016/j.cct.2018.03.014. Epub 
      2018 Mar 27.