Effect of 12-week intermittent calorie restriction compared to standard of care in patients with nonalcoholic fatty liver disease: a randomized controlled trial.
Dietary therapy
Elastography
Fibrosis
Intermittent calorie restriction
MRI-proton density fat fraction
Nonalcoholic fatty liver disease
Nonalcoholic steatohepatitis
Steatosis
Weight reduction
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
02 Aug 2023
02 Aug 2023
Historique:
received:
01
11
2022
accepted:
08
06
2023
medline:
4
8
2023
pubmed:
3
8
2023
entrez:
2
8
2023
Statut:
epublish
Résumé
Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease. NAFLD can result in various complications. Owing to the lack of effective pharmacological therapies, lifestyle modifications are the cornerstone treatment for NAFLD. However, there has been no recommendation for a specific dietary therapy. Because no significant effects have been observed in previous studies. Intermittent calorie restriction (ICR) consists of alternating phases of extreme energy restriction and regular energy intake. Recent studies have demonstrated a significantly higher reduction in liver fat content in the ICR group than in the standard of care (SOC) or continuous calorie restriction groups in patients with NAFLD. However, critical weaknesses limit the broader application of ICR in clinical practice; those are a lack of appropriate assessment tools, different cutoffs of body mass index (BMI) used to define obesity, and different food portions. Thus, we report a protocol for a prospective, randomized controlled trial. The trial will evaluate the effect of 12-week ICR on improving liver fat content in NAFLD patients (Nonalcoholic Fatty Liver Disease-Intermittent Calorie Restriction [FLICR]). We will include adult (19-75 years) NAFLD patients. NAFLD will be diagnosed by histologic assessment or magnetic resonance imaging-proton density fat fraction (MRI-PDFF) ≥ 8%. A total of 72 patients will be classified according to BMI (obese group: BMI ≥ 25 kg/m This FLICR study may provide clinical evidence on ICR in the treatment of NAFLD in both obese and non-obese patients. The use of ICR in patients with NAFLD will improve the clinical outcomes of patients facing a shortage of effective medical therapy. This trial was registered at the United States National Library of Medicine (NLM) at the National Institutes of Health. gov NCT05309642. Registered on April 4, 2022.
Sections du résumé
BACKGROUND
BACKGROUND
Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease. NAFLD can result in various complications. Owing to the lack of effective pharmacological therapies, lifestyle modifications are the cornerstone treatment for NAFLD. However, there has been no recommendation for a specific dietary therapy. Because no significant effects have been observed in previous studies. Intermittent calorie restriction (ICR) consists of alternating phases of extreme energy restriction and regular energy intake. Recent studies have demonstrated a significantly higher reduction in liver fat content in the ICR group than in the standard of care (SOC) or continuous calorie restriction groups in patients with NAFLD. However, critical weaknesses limit the broader application of ICR in clinical practice; those are a lack of appropriate assessment tools, different cutoffs of body mass index (BMI) used to define obesity, and different food portions. Thus, we report a protocol for a prospective, randomized controlled trial. The trial will evaluate the effect of 12-week ICR on improving liver fat content in NAFLD patients (Nonalcoholic Fatty Liver Disease-Intermittent Calorie Restriction [FLICR]).
METHODS
METHODS
We will include adult (19-75 years) NAFLD patients. NAFLD will be diagnosed by histologic assessment or magnetic resonance imaging-proton density fat fraction (MRI-PDFF) ≥ 8%. A total of 72 patients will be classified according to BMI (obese group: BMI ≥ 25 kg/m
DISCUSSION
CONCLUSIONS
This FLICR study may provide clinical evidence on ICR in the treatment of NAFLD in both obese and non-obese patients. The use of ICR in patients with NAFLD will improve the clinical outcomes of patients facing a shortage of effective medical therapy.
TRIAL REGISTRATION
BACKGROUND
This trial was registered at the United States National Library of Medicine (NLM) at the National Institutes of Health.
CLINICALTRIALS
RESULTS
gov NCT05309642. Registered on April 4, 2022.
Identifiants
pubmed: 37533096
doi: 10.1186/s13063-023-07444-4
pii: 10.1186/s13063-023-07444-4
pmc: PMC10394920
doi:
Banques de données
ClinicalTrials.gov
['NCT05309642']
Types de publication
Randomized Controlled Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
490Subventions
Organisme : Ministry of Science and ICT
ID : 2018R1A5A2025286
Organisme : Ministry of Science and ICT
ID : 2022R1I1A1A01065244
Organisme : Ministry of Trade, Industry & Energy
ID : 20013712
Informations de copyright
© 2023. The Author(s).
Références
J Obes Metab Syndr. 2019 Mar;28(1):40-45
pubmed: 31089578
Hepatology. 2019 Jun;69(6):2672-2682
pubmed: 30179269
Am J Clin Nutr. 2018 Nov 1;108(5):933-945
pubmed: 30475957
J Hepatol. 2018 Dec;69(6):1349-1356
pubmed: 30142427
Hepatology. 2018 Jan;67(1):328-357
pubmed: 28714183
Hepatology. 2021 May;73(5):2028-2038
pubmed: 33111374
J Hepatol. 2020 Dec;73(6):1322-1332
pubmed: 32610115
Sci Rep. 2019 Aug 2;9(1):11232
pubmed: 31375753
Gastroenterology. 2021 Feb;160(3):912-918
pubmed: 33307021
Hepatology. 2023 May 1;77(5):1797-1835
pubmed: 36727674
Int J Obes (Lond). 2011 May;35(5):714-27
pubmed: 20921964
Gastroenterology. 2009 May;136(5):1552-60
pubmed: 19208352
Clin Nutr. 2019 Oct;38(5):2023-2030
pubmed: 30314924
Clin Mol Hepatol. 2021 Oct;27(4):553-559
pubmed: 34098712
Br J Nutr. 2013 Oct;110(8):1534-47
pubmed: 23591120
Nutrients. 2021 Dec 26;14(1):
pubmed: 35010966
Clin Mol Hepatol. 2021 Jul;27(3):363-401
pubmed: 34154309
Am J Clin Nutr. 2018 Nov 1;108(5):909-910
pubmed: 30475966
Atherosclerosis. 2018 Dec;279:52-61
pubmed: 30408717
Gastroenterology. 2005 Jul;129(1):113-21
pubmed: 16012941
Hepatology. 2011 May;53(5):1504-14
pubmed: 21400557
JHEP Rep. 2021 Feb 17;3(3):100256
pubmed: 33898960
Am J Clin Nutr. 2011 May;93(5):1048-52
pubmed: 21367948