Non-alcoholic Fatty Liver Disease Clinical Trial
Official title:
Serine Supplementation in Nonalcoholic Fatty Liver Disease
In this study, the investigators aim to increase the liver tissue level of GSH in NAFLD patients by short-term dietary serine supplementation and improve their liver function by lowering the oxidative stress resulting from hepatic steatosis.
There is a strong correlation between major adverse health consequences of obesity and
development of non-alcoholic fatty liver disease (NAFLD). NAFLD is characterized by abnormal
hepatic accumulation of triglycerides and other lipids. It has become a worldwide health
problem that accelerates cirrhosis, type 2 diabetes mellitus (T2DM), and especially
premature cardiovascular morbidity and mortality.
The plasma level of glutathione (GSH) is typically depleted in individuals with metabolism
related disorders. However, cellular GSH levels cannot be increased by supplementing GSH and
it must be synthesized within the liver either de novo or by salvation pathway. The
investigators found that the level of GSH is not enough to maintain and regulate the thiol
redox status of the liver in subjects with high hepatic steatosis at fasting stage due to
the depletion of glycine. Glycine can be synthesized via the interconversion of serine
through serine hydroxymethyl transferases (SHMT1 and SHMT2) with concomitant conversion of
tetrahydrofolate (THF) into 5,10-methylene-THF (CH2-THF). It has been shown that the serine
synthesis is downregulated in patients with NAFLD and supplementation of serine has
attenuated alcoholic fatty liver by enhancing homocysteine metabolism in mice and rats.
In this study, the investigators aim to increase the liver tissue level of GSH in NAFLD
patients by short-term dietary serine supplementation and improve their liver function by
lowering the oxidative stress resulting from hepatic steatosis.
Ten obese patients (BMI 30 - 39.9 kg/m2) with ultrasound and CT-verified non-alcoholic fatty
liver disease (NAFLD). Subjects will be recruited from the Swedish CArdioPulmonary bioImage
Study (SCAPIS) in Gothenburg. The participants in this study (50-65-year-old men and women)
are randomly recruited from the Swedish Population and Address Register. Currently, 1050
subjects have been analyzed and 5000 additional subjects will be analyzed over the next 2
years. By January 2015, over 2000 subjects have been analyzed. Each subject is extensively
phenotyped over two days. This includes extensive blood samples, anthropometry, carotid and
liver ultrasound, and a CT examination that includes coronary calcium score, CT angiography
of coronary arteries, thoracic aorta, and assessment of epicardial fat, liver fat, and
subcutaneous abdominal fat.
Preliminary analysis of the first 1050 subjects indicates that approximately 20% fulfill the
criteria for NAFLD, consistent with data in other western populations.
;
Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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 |