Effects of Carnitine Supplementation on Liver and Muscle (ECLIPSE)

U

University of Nottingham

Status

Completed

Conditions

Insulin Resistance
Non-Alcoholic Fatty Liver Disease

Treatments

Dietary Supplement: L-Carnitine tartrate
Dietary Supplement: Maltodextrin
Dietary Supplement: Meal Replacement Drink

Study type

Interventional

Funder types

Other

Identifiers

NCT03439917
17/EM/0441 (Other Identifier)
17086

Details and patient eligibility

About

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.

Full 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

Enrollment

30 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

30 participants in 2 patient groups, including a placebo group

Carnitine and Meal Replacement Drink
Experimental group
Description:
2g L-carnitine tartrate consumed with a meal replacement milkshake (Slimfast, UK) twice a day for 24 weeks.
Treatment:
Dietary Supplement: Meal Replacement Drink
Dietary Supplement: L-Carnitine tartrate
Placebo and Meal Replacement Drink
Placebo Comparator group
Description:
2g Maltodextrin consumed with a meal replacement milkshake (Slimfast, UK) twice a day for 24 weeks.
Treatment:
Dietary Supplement: Meal Replacement Drink
Dietary Supplement: Maltodextrin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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