Fatty Liver Clinical Trial
— NAFLD-TRFOfficial title:
Impact of Time-restricted Feeding on Hepatic Steatosis in NAFLD
This is a randomised controlled study of patients with Non-Alcoholic Fatty Liver Disease (NAFLD). Patients will be trained according to the 10 rules of a healthy nutrition according to the German Association for Nutrition (DGE). One arm will undergo Time-Restricted Feeding (TRF) for 12 weeks. The control arm is not subject to any time restrictions concerning eating. It will be investigated whether TRF improves insulin sensitivity, impacts on metabolic inflammation and reduces liver steatosis.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 1, 2024 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Patients with steady medication during the last 3 months. A diabetes mellitus must not be decompensated (HbA1c <6.5%). Patients with advanced fibrosis - defined about the non-invasive Fibroscan-procedure (Fibroscan >13 kPa) - will not be included. Complete inclusion criteria: 1. Age between 18 and 75 years 2. Body Mass Index (BMI) > 25 kg/m2 3. Grade 3 steatosis evaluated by with CAP = 300 dB/m and exclusion of known causes of liver steatosis 4. Liver elastography < 13 kPa 5. Capability to understand the study and the individual consequences of participation 6. Signed and dated declaration of agreement in the forefront of the study Complete exclusion criteria: 1. Liver cirrhosis 2. Hepatocellular carcinoma or non-curative treated carcinoma 3. Alcohol consumption >20g (female) und >30 g (male)/day 4. Other causes of chronic liver disease (HBV, HCV, HDV, HEV, HIV), autoimmune diseases or chronic cholestatic liver disease, hereditary haemochromatosis, Wilson disease, a-1-Antitrypsin deficiency 5. Medications which cause liver disease or secondary NAFLD (e. g. Tamoxifen, systemic Corticosteroids, Methotrexate, Tetracycline, Estrogens, Valproic acid) 6. Changes in body weight > 5% in the last 6 months 7. Statins and/ or other fat-reducer medications if not taken in steady dosage during at least 4 weeks 8. Uncontrolled diabetes type 2 defined as HbA1c value > 9.0% or insulin depending type 2 diabetes 9. Pregnancy 10. Immunologic or inflammatory disease (e. h. systemic lupus erythematodes) 11. Patients after organ transplantations 12. Missing or lacking consent capability |
Country | Name | City | State |
---|---|---|---|
Germany | University Medical Center of the Johannes Gutenberg Univeristy | Mainz | Rheinland-Pfalz |
Lead Sponsor | Collaborator |
---|---|
Johannes Gutenberg University Mainz | University of Turin, Italy |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of the impact of TRF on liver steatosis by CAP (dB/m) | The primary outcome of interest is a change in CAP value of a least 20 db/m with TRF | 12 weeks | |
Secondary | Changes in liver fibrosis by liver stiffness (kPa) under TRF | Liver elastography performed as surrogate marker of liver fibrosis | 12 weeks | |
Secondary | Changes in FIB-4 as indirect non-invasive tools of liver fibrosis | Changes in the surrogate marker of liver fibrosis FIB-4 | 12 weeks | |
Secondary | Evaluation of changes in direct non-invasive tool of liver fibrosis ELF | Performed as surrogate markers of liver fibrosis | 12 weeks | |
Secondary | Evaluation of changes in direct marker of liver fibrogenesis PRO-C3 (ng/ml) | Performed as surrogate markers of liver fibrosis | 12 weeks | |
Secondary | Evaluation of changes in liver-specific quality of life | Evaluation of Patient Reported Outcomes using the Chronic Liver Disease Questionnaire (CLDQ). The CLDQ uses 29 items in four domains, each scored on a Likert scale from 1 (all of the time) to 7 (none of the time) representing the frequency of clinical symptoms and emotional problems in the last two weeks. Results are reported in the six subscale scores (abdominal symptoms, fatigue, systemic symptoms, activity, emotional functioning, worry) and a CLDQ overall score. | 12 weeks | |
Secondary | Evaluation of changes in insulin sensitivity | Changes in insulin sensitivity by indexes derived by HOMA-IR score | 12 weeks | |
Secondary | Evaluation of changes in the gut microbiota | Evaluation of 16S rRNA gene sequencing for species and strain-level microbiome analysis. | 12 weeks | |
Secondary | Evaluation of changes in markers of oxidative stress (AGEs) | AGEs as surrogate markers of oxidative stress | 12 weeks | |
Secondary | Changes in spleen volume by spleen stiffness under TRF | Spleen stiffness performed as surrogate of spleen volume | 12 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05979779 -
Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis
|
Phase 2 | |
Recruiting |
NCT06051669 -
Comparison of iLivTouch and FibroScan for the Assessment of Liver Fibrosis and Steatosis in Adult Patients in the US
|
||
Not yet recruiting |
NCT05984745 -
Effect of CoQ10 on the Outcome of MAFLD Patients
|
Phase 2 | |
Completed |
NCT02565446 -
Transforming Non-Invasive Liver Disease Detection by MRE: The Hepatogram
|
N/A | |
Not yet recruiting |
NCT01694342 -
Telomere Parameters in Patients With Nonalcoholic Fatty Liver
|
N/A | |
Completed |
NCT01464801 -
Resveratrol in Patients With Non-alcoholic Fatty Liver Disease
|
N/A | |
Completed |
NCT01992809 -
Omega 3 Supplementation in Fatty Liver
|
Phase 3 | |
Completed |
NCT00063635 -
Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)
|
Phase 3 | |
Completed |
NCT00244569 -
Development of a Breath Test for Monitoring Patients With Liver Disease
|
Phase 3 | |
Recruiting |
NCT03972319 -
Omega-3 Supplementation for LIver VolumE Reduction Study (OLIVER) Study
|
Early Phase 1 | |
Completed |
NCT03141008 -
Evaluation of Liver and Cardiometabolic Health Benefits on Low Carbohydrate Ketogenic Diet
|
||
Completed |
NCT03614039 -
Effect of Probiotic and Smectite Gel on NAFLD
|
N/A | |
Recruiting |
NCT05125757 -
Lifestyle Modification in Psoriatic Patients With Fatty Liver
|
N/A | |
Recruiting |
NCT05370053 -
The Availability of the Enhanced Liver Fibrosis (ELF) Test Affects the Rate of Diagnosis of Nonalcoholic Steatohepatitis (NASH) With Fibrosis in Patients Referred to Hepatology
|
N/A | |
Recruiting |
NCT04371042 -
PROtocol of Metabolic and Cryptogenic livEr Disease regisTry for intEgration of Omic Studies
|
||
Completed |
NCT04004273 -
Diabetes, Exercise and Liver Fat (DELIVER)
|
N/A | |
Completed |
NCT02520609 -
Dynamic Post-Prandial Metabolism in Patients With Non-Alcoholic Fatty Liver Disease
|
||
Recruiting |
NCT02265276 -
A Prospective, Randomized Trial to Compare saroGLitazar With pioglitAZone in Nonalcoholic Fatty livEr Disease
|
Phase 3 | |
Completed |
NCT02347007 -
Impact of Almond Supplementation on Body Composition in Overweight/Obese Minority Adults
|
N/A | |
Completed |
NCT01934777 -
Efficacy and Tolerance of Treatment With DHA, Choline and Vitamin E in Children With Non-alcoholic Steatohepatitis
|
Phase 3 |