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
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.
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. ;
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 |