Non-alcoholic Fatty Liver Disease Clinical Trial
Official title:
Prebiotic Fibre Supplementation and Gut Microbiota in Non-alcoholic Fatty Liver Disease
NCT number | NCT02568605 |
Other study ID # | UC-REB14-2464 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2015 |
Est. completion date | August 2022 |
Verified date | October 2022 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Non-alcoholic fatty liver disease (NAFLD) is a condition where accumulation of fat in the liver leads to metabolic dysfunction. Currently there are no approved treatments for NAFLD. Part of the metabolic dysfunction may arise through changes in the gut microbiota. Prebiotic fibres have beneficial effects on glucose tolerance, body weight, and gut microbiota; therefore they may have potential as part of a dietary strategy for NAFLD treatment.
Status | Completed |
Enrollment | 45 |
Est. completion date | August 2022 |
Est. primary completion date | August 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Adult subjects diagnosed with NAFLD on the basis of abnormal liver enzymes (ALT>1.5x upper limit of normal) and ultrasonography - Exclusion of other causes of liver disease including viral hepatitis and alcoholic liver disease - Aspartate aminotransferase and alanine aminotransferase =10x upper limit of normal - Patients with type 2 diabetes treated with diet and exercise alone or metformin Exclusion Criteria: - Cirrhosis of the liver (FibroScan >17.5 kilopascal or FibroTest >0.8) or clinical features of cirrhosis. - Alcohol consumption >20g/day (2 standard drinks) in women or > 30g/d (3 drinks) in men - Alternate (e.g. TPN) or concomitant etiology for abnormal liver enzymes. - History of decompensated liver disease including ascites, encephalopathy or variceal bleeding - Concomitant use of any weight loss medication, previous bariatric or other intestinal surgery - Presence of active infection, pregnancy or lactation - Regular use of a probiotic or prebiotic supplement within 3 months prior to enrollment - Antibiotic use within 3 months prior to enrollment - Weight loss >3 kg within preceding 3 months to enrollment - Uncontrolled cardiovascular or respiratory disease, active malignancy, or chronic infections - Use of agents such as vitamin E, omega-3 fatty acids or medications with evidence for effects on NAFLD (pioglitazone, Glucagon-like peptide-1 analogues, dipeptidyl peptidase IV inhibitors, ursodeoxycholic acid) - Patients with type 2 diabetes where HbA1c is >9% |
Country | Name | City | State |
---|---|---|---|
Canada | University of Calgary | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary | Canadian Institutes of Health Research (CIHR) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Liver Fat | Assessed via MRI | 24 weeks | |
Primary | Change in Liver Fibrosis | Assessed via FibroScan (transient elastography) | 24 weeks | |
Primary | Change in Liver Injury | Assessed via Fibrotest Score (composite score from serum biochemical markers: alfa2-macroglobulin, apolipoproteinA1, total bilirubin, haptoglobin, gamma glutamyl transpeptidase, alanine aminotransferase) | 24 weeks | |
Secondary | Change in Glucose Tolerance | Assessed via an oral glucose tolerance test | 24 weeks | |
Secondary | Change in Glycemic Control | Assessed via HbA1c | 24 weeks | |
Secondary | Change in Subjective Appetite | Assessed via Subjective appetite ratings on a visual analogue scale | 24 weeks | |
Secondary | Change in Satiety Hormones | Assessed in serum as pg/ml (Ghrelin, Glucagon-like peptide-1, Glucose-dependent insulinotropic polypeptide, leptin and Peptide tyrosine tyrosine) | 24 weeks | |
Secondary | Change in Body Composition | Assessed via dual x-ray absorptiometry | 24 weeks | |
Secondary | Change in Quality of Life | Assessed via the Short Form-36v2 Health Survey questionnaire | 24 weeks | |
Secondary | Dietary Adherence | Assessed via adherence to prescribed versus measured energy intake assessed by food records | 24 weeks | |
Secondary | Examine mechanisms related to prebiotic-induced changes in gut microbiota, their metabolic byproducts, and de novo lipogenesis | Via investigating gut microbiota shot-gun sequencing and measurement of volatile organic compounds and de novo lipogenesis using deuterium incorporation | 24 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05480696 -
Soluble Fibre Supplementation in NAFLD
|
Phase 1 | |
Active, not recruiting |
NCT02500147 -
Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS)
|
Phase 4 | |
Completed |
NCT04671186 -
Role of Probiotics in Treatment of Pediatric NAFLD Patients by Assessing With Fibroscan
|
N/A | |
Recruiting |
NCT05979779 -
Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis
|
Phase 2 | |
Recruiting |
NCT05462353 -
Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH
|
Phase 2 | |
Completed |
NCT05006885 -
ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)
|
Phase 1 | |
Completed |
NCT04117802 -
Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome
|
N/A | |
Recruiting |
NCT04365855 -
The Olmsted NAFLD Epidemiology Study (TONES)
|
N/A | |
Recruiting |
NCT05618626 -
Prevention of NAFLD and CVD Through Lifestyle Intervention
|
N/A | |
Completed |
NCT03256526 -
6-week Safety and PD Study in Adults With NAFLD
|
Phase 2 | |
Enrolling by invitation |
NCT06152991 -
Clinical Trial Assessing Godex Carnitine Orotate Complex in Nonalcoholic Fatty Liver Disease Patients for Efficacy
|
Phase 3 | |
Completed |
NCT03681457 -
Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects
|
Phase 1 | |
Completed |
NCT06244550 -
Clinical Trials Using HepatoKeeper Herbal Essentials to Treat Non-alcoholic Fatty Liver Disease and Metabolic Factors
|
N/A | |
Not yet recruiting |
NCT05120557 -
Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH
|
N/A | |
Completed |
NCT03060694 -
Screening Diabetes Patients for NAFLD With Controlled Attenuation Parameter and Liver Stiffness Measurements
|
||
Completed |
NCT02526732 -
Hepatic Inflammation and Physical Performance in Patients With NASH
|
N/A | |
Recruiting |
NCT01988441 -
The Influence of Autophagy on Fatty Liver
|
||
Recruiting |
NCT01680003 -
Hepar-P Study to Evaluate the Safety and Efficacy of a Standardised Extract of Phyllanthus Niruri for the Treatment of Non-alcoholic Fatty Liver Disease
|
Phase 2 | |
Completed |
NCT01712711 -
Helicobacter Pylori Eradication in Diabetic Subjects With Non-alcoholic Fatty Liver Disease
|
Phase 2 | |
Recruiting |
NCT00941642 -
Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease
|
Phase 4 |