Evidence mapPaperPMID 37533096Full record

Trial reportTrials2023

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

Han Ah Lee, Hyeyoung Moon, Yuri Kim, Hye Ah Lee, Hwi Young Kim

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05309642 (Effect of 12-week Intermittent Calorie Restriction on Liver Fat Content in Comparison With Standard-of-care in Patients With Nonalcoholic Fatty Liver Disease), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05309642 nacompletednot on this map

Effect of 12-week Intermittent Calorie Restriction on Liver Fat Content in Comparison With Standard-of-care in Patients With Nonalcoholic Fatty Liver Disease: a Randomized Controlled Trial

TypeinterventionalSponsorEwha Womans University Mokdong HospitalRan2022 to 2023Enrolled72ConditionsNonalcoholic Fatty Liver, Nonalcoholic SteatohepatitisArmsIntermittent calorie restriction, Standard of care
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Han Ah LeeDepartment of Internal Medicine, College of Medicine, Ewha Womans University, 1071 Anyangcheon-Ro, Yangcheon-Gu, Seoul, 07985, Republic of Korea.ORCID http://orcid.org/0000-0002-0430-1607
Hyeyoung MoonNutritional Science and Food Management, Ewha Womans University, Seoul, Republic of Korea.
Yuri KimNutritional Science and Food Management, Ewha Womans University, Seoul, Republic of Korea.
Hye Ah LeeClinical Trial Center, Ewha Womans University Seoul Hospital, Seoul, Republic of Korea.
Hwi Young KimDepartment of Internal Medicine, College of Medicine, Ewha Womans University, 1071 Anyangcheon-Ro, Yangcheon-Gu, Seoul, 07985, Republic of Korea. hwiyoung@ewha.ac.kr.ORCID http://orcid.org/0000-0003-0723-1285
Ewha Womans University · KR

Funding

Ministry of Science and ICT 2018R1A5A2025286Ministry of Science and ICT 2022R1I1A1A01065244Ministry of Trade, Industry & Energy 20013712
6 · The paper itself

Abstract

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/m DISCUSSION: 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 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.

Indexed as

Non-alcoholic Fatty Liver DiseaseAdultCaloric RestrictionHumansLiverMagnetic Resonance ImagingProspective StudiesStandard of CareDietary therapyElastographyFibrosisIntermittent calorie restrictionMRI-proton density fat fractionNonalcoholic fatty liver diseaseNonalcoholic steatohepatitisSteatosisWeight reduction

Identifiers

PMID37533096
PMCPMC10394920
OpenAlexW4385494630

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.