Non-alcoholic Fatty Liver Disease (NAFLD) Clinical Trial
— CHOTOfficial title:
How Does Dietary Carbohydrate Influence the Formation of an Atherogenic Lipoprotein Phenotype?
Verified date | May 2021 |
Source | University of Surrey |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The hypothesis of this study is that a diet high in sugars will increase abnormalities in blood lipids which are associated with increased cardiovascular disease risk, relative to a diet which is low in sugar. We predict that this potentially adverse effect of dietary sugars on blood lipids will be more pronounced in people with a raised level of stored fat inside their liver, as compared to people with a low level of stored fat.
Status | Completed |
Enrollment | 27 |
Est. completion date | September 2012 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Male gender, - Increased cardio-metabolic risk ('RISCK' criteria Jebb et al (2010) Am J Clin Nutr 92, 748-758). - Apo E3E3 genotype Exclusion Criteria: - Any abnormal result in blood screen (renal and liver function, haematology) - Diabetes - Smoker - Excessive alcohol consumption (>27units/week) - Medication likely to affect lipid metabolism - >3kg weight loss in preceding 3 months - Any medical condition (eg. GI tract, allergies) affecting lipid metabolism or ability to comply with dietary interventions - Involvement in any other study |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Surrey | Guildford | Surrey |
Lead Sponsor | Collaborator |
---|---|
Bruce A. Griffin | Imperial College London, University of Cambridge |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Production Rate of VLDL-1 Triacylglycerol (TAG) | The in vivo production rate of VLDL-1 TAG, trace-labelled with [1,1,2,3,3-H5] glycerol, measured in units of grams/day. | After (post-diet) two 12 week diets (high sugar versus low sugar) in men with NAFLD (n=11) versus Controls (n=14) | |
Primary | Production Rate VLDL-1 Apoprotein B | The in vivo production rate of VLDL-1 apoprotein B, trace-labelled with [I-13C] leucine (leucine with carbon-13), measured in units of milligrams/day. | After (post-diet) two 12 week diets (high sugar versus low sugar) in men with NAFLD (n=11) versus Controls (n=14) | |
Secondary | Kinetics of Systemic Non-esterified Fatty Acids by [C-13]-Trace-labelled Palmitate | Palmitate was labelled in vivo by the infusion of [U-13 carbon]. This provides a measure of the rate of intra-cellular lipolysis and contribution of systemic palmitate to the synthesis of triacylglycerol in the liver in units of micro mols/L (umol/L). | After (post-diet) two 12 week diets (high sugar versus low sugar) in men with NAFLD (n=11) versus Controls (n=14) | |
Secondary | De Novo Lipogenesis (Rate of Triacylglycerol (TAG) Synthesis in the Liver) as Measured by Contribution to VLDL-1 TAG Production Rate | Acetyl CoA (Co-enzyme-A) is labelled in vivo by the consumption of [2H20] (2H20=deuterated 'heavy'-labelled water). Recovery and detection of this label in VLDL-1 by GC-MS (Gas Chromatography-Mass Spectrometry), provides a measure of fatty acid and TAG synthesis in the liver in terms of its contribution to the production rate of VLDL-1 TAG in units of grams/day. | After (post-diet) two 12 week diets (high sugar versus low sugar) in men with NAFLD (n=11) versus Controls (n=14) | |
Secondary | Intra-hepatocellular Lipid (IHCL) or % Liver Fat | Percentage of intra-hepatocellular lipid (IHCL or % liver fat) was measured by magnetic resonance spectroscopy (MRS). | After (post-diet) two 12 week diets (high sugar versus low sugar) in men with NAFLD (n=11) versus Controls (n=14) | |
Secondary | Plasma Concentration of Triacylglycerol | Plasma concentration of triacylglycerol (TAG) was measured in the post-absorptive state (after 12h fast) and expressed in units of mmol/L (shown as log transformed geometric means) | After (post-diet) two 12 week diets (high sugar versus low sugar) in men with NAFLD (n=11) versus Controls (n=14) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04099147 -
Diagnosis and Characterization of Non-Alcoholic Fatty Liver Disease Based on Artificial Intelligence.
|
||
Completed |
NCT04019561 -
A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH.
|
Phase 2 | |
Withdrawn |
NCT00375349 -
Non Alcoholic Fatty Liver Disease Influence of Statin Therapy
|
N/A | |
Active, not recruiting |
NCT04682600 -
The Sonic Incytes Liver Incytes System, Evaluation of Liver Fibrosis and Steatosis Versus MRE and MRI PDFF
|
N/A | |
Terminated |
NCT02605616 -
Use of a Novel Drug in People With Non-alcoholic Steatohepatitis (NASH) or Non-alcoholic Fatty Liver Disease (NAFLD)
|
Phase 2 | |
Completed |
NCT04165343 -
Evaluation of Multi-Organ Metabolism and Perfusion in NAFLD by Total Body Dynamic PET Scan on EXPLORER
|
||
Recruiting |
NCT03151473 -
Longitudinal Observational Study Of Chinese With NAFLD/NASH
|
||
Recruiting |
NCT04820036 -
A Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG)
|
N/A | |
Active, not recruiting |
NCT02037321 -
Meta-Analyses of the Effect of Vegetable Protein for Animal Protein on Cardiometabolic Risk
|
N/A | |
Completed |
NCT01997424 -
Association of Non-alcoholic Fatty Liver Disease and Diabetes Mellitus
|
N/A | |
Completed |
NCT01110577 -
Study of Magnetic Resonance Imaging (MRI) to Quantify Liver Fat in Diabetic and Pre-Diabetic Patients (0000-171)
|
N/A | |
Completed |
NCT00771108 -
Exercise Dose and Nonalcoholic Fatty Liver Disease
|
N/A | |
Recruiting |
NCT04639414 -
Combined Active Treatment in Type 2 Diabetes With NASH
|
Phase 4 | |
Completed |
NCT04450875 -
Efficacy of Nutritional Therapy With High Methionine Content in the Treatment of NAFLD
|
N/A | |
Recruiting |
NCT02654665 -
Comparing Effects of Liraglutide and Bariatric Surgery on Weight Loss, Liver Function, Body Composition, Insulin Resistance, Endothelial Function and Biomarkers of Non-alcoholic Steatohepatitis (NASH) in Obese Asian Adults
|
Phase 3 | |
Recruiting |
NCT05699018 -
Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients
|
N/A | |
Withdrawn |
NCT02457286 -
Improving Insulin Resistance To Treat Non-Alcoholic Fatty Liver Disease: A Pilot Study
|
Phase 1 | |
Withdrawn |
NCT02194894 -
The Effect of Acetaminophen on Non-alcoholic Fatty Liver Disease Patients
|
N/A | |
Completed |
NCT01811472 -
Study to Assess the Efficacy, Safety and Tolerability of LCQ908 in NAFLD Patients
|
Phase 2 | |
Completed |
NCT00968747 -
Regulation of FGF21 by Nutritional Challenges
|
N/A |