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| ID | Type | Description | Link |
|---|---|---|---|
| 17/EM/0441 | Other Identifier | REC Reference |
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| Name | Class |
|---|---|
| Nottingham University Hospitals NHS Trust | OTHER |
| National Institute for Health Research, United Kingdom | OTHER_GOV |
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It will be evaluated whether carnitine, a dietary supplement, reduces liver fat and improves metabolism in individuals who have a high concentration of fat within their liver. Participants will be given either Carnitine or placebo, together with a meal replacement milkshake twice daily for 6 months.
NAFLD occurs when too much fat accumulates in liver tissue. This can, over time, cause inflammation and scarring of the liver, eventually leading to chronic liver disease and cirrhosis. It is strongly associated with diabetes and obesity, both of which are endemic in Western societies.
Carnitine enables cells in the body to use fat as a fuel, and recent studies have suggested that carnitine supplementation may reduce liver triglyceride content. Muscle and liver are the major sites in the body which coordinate glucose and fat metabolism. As well as assessing the effect of carnitine supplementation on liver fat, its effect on metabolic processes within these tissues will also be measured
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carnitine and Meal Replacement Drink | Experimental | 2g L-carnitine tartrate consumed with a meal replacement milkshake (Slimfast, UK) twice a day for 24 weeks. |
|
| Placebo and Meal Replacement Drink | Placebo Comparator | 2g Maltodextrin consumed with a meal replacement milkshake (Slimfast, UK) twice a day for 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-Carnitine tartrate | Dietary Supplement | 2g L-Carnitine tartrate as a powder consumed twice a day |
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| Measure | Description | Time Frame |
|---|---|---|
| Intrahepatic triglyceride (IHTG) content | IHTG measured by proton magnetic resonance spectroscopy | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| liver sensitivity to insulin | suppression of glucose output from the liver during a 20 mU.m-2.min-1 hyperinsulinaemic euglycaemic clamp | 24 weeks |
| whole body insulin sensitivity | whole body glucose uptake during a 50 mU.m-2.min-1 hyperinsulinaemic euglycaemic clamp |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guru Aithal, MD, PhD | University of Nottingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David Greenfield Human Physiology Unit | Nottingham | Notts | NG72UH | United Kingdom |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006946 | Hyperinsulinism |
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| ID | Term |
|---|---|
| C478492 | slif protein, Drosophila |
| C008315 | maltodextrin |
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| Meal Replacement Drink | Dietary Supplement | 325ml dairy-based meal replacement drink ('Slimfast' trademark of KSF Acquisition UK Ltd) consumed twice a day |
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| Maltodextrin | Dietary Supplement | 2g Maltodextrin powder packaged to mimic carnitine powder consumed twice a day |
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| 24 weeks |
| Muscle lipid content | lipid content of the vastus lateralis muscle measured by proton magnetic resonance spectroscopy | 24 weeks |
| Skeletal muscle sensitivity to insulin | Arterialised-venous vs. femoral venous difference in blood glucose concentration during the last hour of a 2 hour 50 mU.m-2.min-1 hyperinsulinaemic euglycaemic clamp | 24 weeks |
| whole body composition | Fat and lean tissue mass assessment by dual energy X-ray absorptiometry | 24 weeks |
| Liver energy metabolism | hepatic ATP flux assessed by 31-phosphorous magnetic resonance spectroscopy | 24 weeks |
| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |