Effect of 12-week intermittent calorie restriction compared to standard of care in patients with nonalcoholic fatty liver disease: a randomized controlled trial

Trials

Study Protocol

Hye Ah Lee¹  Hwi Young Kim²  Han Ah Lee²  Yuri Kim³  Hyeyoung Moon³ 

[1] Clinical Trial Center, Ewha Womans University Seoul Hospital, Seoul, Republic of Korea;Department of Internal Medicine, College of Medicine, Ewha Womans University, 1071 Anyangcheon-Ro, Yangcheon-Gu, 07985, Seoul, Republic of Korea;Nutritional Science and Food Management, Ewha Womans University, Seoul, Republic of Korea;

关键词: Nonalcoholic fatty liver disease;    Nonalcoholic steatohepatitis;    Intermittent calorie restriction;    Steatosis;    Fibrosis;    MRI-proton density fat fraction;    Elastography;    Weight reduction;    Dietary therapy;   

DOI  :  10.1186/s13063-023-07444-4

 received in 2022-11-01, accepted in 2023-06-08,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundNonalcoholic 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]).MethodsWe 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/m2 [n = 36] and non-obese group: BMI < 25 kg/m2 [n = 36]). Participants will be followed up for 24 weeks. Participants will be randomly assigned to one of the two groups: the SOC or ICR group. The primary objective will be the change in liver fat content measured using MRI-PDFF from baseline to 12 weeks.DiscussionThis 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 registrationThis trial was registered at the United States National Library of Medicine (NLM) at the National Institutes of Health. ClinicalTrials.gov NCT05309642. Registered on April 4, 2022.

【 授权许可】

CC BY   
© The Author(s) 2023

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