Clinical Trials Logo
  1. Home
  2. Nonalcoholic Steatohepatitis
  3. NCT05309642

Nonalcoholic Fatty Liver Disease - Intermittent Calorie Restriction (FLICR) Study

Nonalcoholic Steatohepatitis Clinical Trial

Official title:
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

Clinical Trial Summary

Several diets have been proposed to reduce liver steatosis in patients with nonalcoholic fatty liver disease (NAFLD), and various effects on liver steatosis have been observed. The objective of this trial is to compare the effects of intermittent calorie restriction (ICR) (5:2 diet) and standard-of-care (SoC) on reduction of hepatic steatosis.

Clinical Trial Description

This is an open-label randomised controlled trial of patients with NAFLD. Patients are recruited in the Liver Outpatient Clinic of the Ewha Womans University Mokdong Hospital. The department of Nutritional Science and Food Management, Ewha Womans University will collaborate for this study. About 72 patients (36 patients with body mass index [BMI] ≥25 kg/m2 and 36 patients with BMI <25 kg/m2) will be enrolled in a 1:1 ratio to 12 weeks treatment with either 5:2 diet (ICR group, 18 patients in each BMI group), or general lifestyle advice from a hepatologist (standard of care; SoC group, 18 patients in each BMI group). Beginning in week 3 (Visit 2), an ICR group and a SoC group are generated through randomisation. Both arms will be accompanied for a duration of 12 weeks. After 12 weeks from the completion of the experimental phase (wash-out period), there will be the "end of follow up" visit. The whole duration of the study is 26 weeks (2 weeks lead-in, 12 weeks intervention and 12 weeks post-intervention investigation). Magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) and MR-Elastography are conducted at the screening visit and at weeks 12. There will be 5 visits at the study center (screening, randomization, week 8, end of treatment and end of study) and 10 phone visits (week 4, 5, 6, 7, 8, 10, 11, 12, 13, 14). At each visit clinical events, anthropometric index and standard laboratory parameters will be collected. Participants will fill in questionnaires capturing quality of life. Adverse events will be recorded. Phone visits are used to survey the safety of patients. Non-adherence to ICR for 20% of the total study period has been selected as cut off to define treatment failure at per-protocol analysis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05309642
Study type Interventional
Source Ewha Womans University Mokdong Hospital
Contact
Status Completed
Phase N/A
Start date March 7, 2022
Completion date December 6, 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT03375008 - Predictable MR Index for Nonalcoholic Steatohepatitis (NASH) N/A
Recruiting NCT05979779 - Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis Phase 2
Withdrawn NCT02769091 - A Study in Adult Patients With Nonalcoholic Steatohepatitis Who Also Have Type 2 Diabetes Phase 2
Completed NCT02654977 - CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Metreleptin in Various Forms of Partial Lipodystrophy Phase 2
Recruiting NCT05211284 - Saroglitazar Magnesium 4 mg for NASH in People Living With HIV in the US Phase 2
Completed NCT02421094 - Clinical Trial to Evaluate Efficacy of GR-MD-02 for Treatment of Liver Fibrosis in Patients With NASH With Advanced Fibrosis Phase 2
Completed NCT01205087 - Safety and Efficacy of Oral Administration of Anti-CD3 Monoclonal Antibody (mAb)in Patients With the Metabolic Syndrome Phase 2
Recruiting NCT00152711 - Impact of nCPAP Treatment on Liver Function in Patients With Sleep Apnea Syndrome and Nonalcoholic Steatohepatitis N/A
Completed NCT02217475 - Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Participants With Liver Fibrosis Phase 2
Completed NCT04031729 - Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease Phase 1/Phase 2
Completed NCT03674476 - An Investigational Study to Evaluate Experimental Medication BMS-986036 in Participants With Different Levels of Kidney Function Phase 1
Recruiting NCT03725631 - Non-invasive Evaluation of Liver Fibrosis, Steatosis, and NASH in NAFLD N/A
Terminated NCT04565717 - A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH) Phase 1
Completed NCT01679197 - Clinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated With Lipodystrophy Phase 2
Active, not recruiting NCT05084404 - Efficacy and Safety of Guanabenz for Nonalcoholic Fatty Liver Disease Phase 2
Active, not recruiting NCT02574325 - A Study to Assess ARI-3037MO on Hepatic Fat Metabolism in Patients With Dysglycemia and Evidence of Hepatic Steatosis Phase 2
Terminated NCT00878592 - Effect of Dietary and Life Style Modification on Post Liver Transplant Obesity N/A
Recruiting NCT02148471 - Fatty Acids, Genes and Microbiota in Fatty Liver N/A
Completed NCT00227110 - Role of Pioglitazone in the Treatment of Non-alcoholic Steatohepatitis (NASH) Phase 4
Completed NCT03656744 - A Study of HTD1801 in Adults With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM) Phase 2