Clinical trial NCT03439917: Effects of Carnitine Supplementation on Liver and Muscle
Official title: Effect of Carnitine Supplementation on Liver Steatosis, Insulin Sensitivity, Plasma Glucose Homeostasis, Skeletal Muscle Metabolism and Energetics: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Insulin Resistance
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Nottingham University Hospitals NHS Trust
name: National Institute for Health Research, United Kingdom
First posted: 2018-02-20
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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

Eligibility criteria: 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, α1-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.

Primary outcomes:
measure: Intrahepatic triglyceride (IHTG) content
timeFrame: 24 weeks
Secondary outcomes:
measure: liver sensitivity to insulin
timeFrame: 24 weeks
measure: whole body insulin sensitivity
timeFrame: 24 weeks
measure: Muscle lipid content
timeFrame: 24 weeks
measure: Skeletal muscle sensitivity to insulin
timeFrame: 24 weeks
measure: whole body composition
timeFrame: 24 weeks
measure: Liver energy metabolism
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: David Greenfield Human Physiology Unit
state: Notts
Study officials:
affiliation: University of Nottingham
name: Guru Aithal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: