Effects of Carnitine Supplementation on Liver and Muscle

Insulin Resistance Clinical Trial

— ECLIPSE  

Official title:

Effect of Carnitine Supplementation on Liver Steatosis, Insulin Sensitivity, Plasma Glucose Homeostasis, Skeletal Muscle Metabolism and Energetics: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03439917
• Other study ID #: 17086
• Secondary ID: 17/EM/0441
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Fatty Liver
• Insulin Resistance
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

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