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OpenTrials
Completed

NCT Number: NCT03439917

Effects of Carnitine Supplementation on Liver and Muscle

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

David Greenfield Human Physiology Unit

Nottingham, Notts, NG72UH, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

L-Carnitine tartrate

Dietary Supplement

2g L-Carnitine tartrate as a powder consumed twice a day

Meal Replacement Drink

Dietary Supplement

325ml dairy-based meal replacement drink ('Slimfast' trademark of KSF Acquisition UK Ltd) consumed twice a day

Other names: Slimfast

Maltodextrin

Dietary Supplement

2g Maltodextrin powder packaged to mimic carnitine powder consumed twice a day

Primary outcomes

  1. Intrahepatic triglyceride (IHTG) content

    Time frame: 24 weeks

    IHTG measured by proton magnetic resonance spectroscopy

Secondary outcomes

  1. liver sensitivity to insulin

    Time frame: 24 weeks

    suppression of glucose output from the liver during a 20 mU.m-2.min-1 hyperinsulinaemic euglycaemic clamp

  2. whole body insulin sensitivity

    Time frame: 24 weeks

    whole body glucose uptake during a 50 mU.m-2.min-1 hyperinsulinaemic euglycaemic clamp

  3. Muscle lipid content

    Time frame: 24 weeks

    lipid content of the vastus lateralis muscle measured by proton magnetic resonance spectroscopy

  4. Skeletal muscle sensitivity to insulin

    Time frame: 24 weeks

    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

  5. whole body composition

    Time frame: 24 weeks

    Fat and lean tissue mass assessment by dual energy X-ray absorptiometry

  6. Liver energy metabolism

    Time frame: 24 weeks

    hepatic ATP flux assessed by 31-phosphorous magnetic resonance spectroscopy

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • National Institute for Health Research, United Kingdom
  • Nottingham University Hospitals NHS Trust

Registry information

Official study title

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

Acronym: ECLIPSE

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Feb 20, 2018
Registry last updated
Nov 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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