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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03439917
Other study ID # 17086
Secondary ID 17/EM/0441
Status Completed
Phase N/A
First received
Last updated
Start date April 2, 2018
Est. completion date November 1, 2021

Study information

Verified date November 2021
Source University of Nottingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 1, 2021
Est. primary completion date August 30, 2020
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Elevated liver fat on screening abdominal ultrasound - Capable of providing informed consent - Non-vegetarian diet - BMI <40 kg/m2 - Weekly ethanol consumption <21 units/week - Negative non-invasive liver screen, including Hepatitis B and C serology, liver autoantibodies, transferrin saturation, a1-antitrypsin levels. Exclusion Criteria: - Known history of cardiovascular disease - Known diabetes mellitus - Known psychiatric comorbidity - Chronic kidney disease - Surgery within 6 months prior to start of study - Exposure to drugs known to influence hepatic steatosis (including steroids, statins, omega-3-fatty acids) - Current smokers - Contraindications to magnetic resonance scanning, including implanted ferrous material (implantable pacemakers or defibrillators), metallic ocular foreign bodies, ferromagnetic aneurysm clips or severe claustrophobia.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
L-Carnitine tartrate
2g L-Carnitine tartrate as a powder consumed twice a day
Meal Replacement Drink
325ml dairy-based meal replacement drink ('Slimfast' trademark of KSF Acquisition UK Ltd) consumed twice a day
Maltodextrin
2g Maltodextrin powder packaged to mimic carnitine powder consumed twice a day

Locations

Country Name City State
United Kingdom David Greenfield Human Physiology Unit Nottingham Notts

Sponsors (3)

Lead Sponsor Collaborator
University of Nottingham National Institute for Health Research, United Kingdom, Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intrahepatic triglyceride (IHTG) content IHTG measured by proton magnetic resonance spectroscopy 24 weeks
Secondary liver sensitivity to insulin suppression of glucose output from the liver during a 20 mU.m-2.min-1 hyperinsulinaemic euglycaemic clamp 24 weeks
Secondary whole body insulin sensitivity whole body glucose uptake during a 50 mU.m-2.min-1 hyperinsulinaemic euglycaemic clamp 24 weeks
Secondary Muscle lipid content lipid content of the vastus lateralis muscle measured by proton magnetic resonance spectroscopy 24 weeks
Secondary 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
Secondary whole body composition Fat and lean tissue mass assessment by dual energy X-ray absorptiometry 24 weeks
Secondary Liver energy metabolism hepatic ATP flux assessed by 31-phosphorous magnetic resonance spectroscopy 24 weeks
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