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Effects of Carnitine Supplementation on Liver and Muscle (ECLIPSE)

Primary Purpose

Non-Alcoholic Fatty Liver Disease, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
L-Carnitine tartrate
Meal Replacement Drink
Maltodextrin
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

18 Years - 50 Years (Adult)MaleDoes not accept 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.

Sites / Locations

  • David Greenfield Human Physiology Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Carnitine and Meal Replacement Drink

Placebo and Meal Replacement Drink

Arm Description

2g L-carnitine tartrate consumed with a meal replacement milkshake (Slimfast, UK) twice a day for 24 weeks.

2g Maltodextrin consumed with a meal replacement milkshake (Slimfast, UK) twice a day for 24 weeks.

Outcomes

Primary Outcome Measures

Intrahepatic triglyceride (IHTG) content
IHTG measured by proton magnetic resonance spectroscopy

Secondary Outcome Measures

liver sensitivity to insulin
suppression of glucose output from the liver during a 20 mU.m-2.min-1 hyperinsulinaemic euglycaemic clamp
whole body insulin sensitivity
whole body glucose uptake during a 50 mU.m-2.min-1 hyperinsulinaemic euglycaemic clamp
Muscle lipid content
lipid content of the vastus lateralis muscle measured by proton magnetic resonance spectroscopy
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
whole body composition
Fat and lean tissue mass assessment by dual energy X-ray absorptiometry
Liver energy metabolism
hepatic ATP flux assessed by 31-phosphorous magnetic resonance spectroscopy

Full Information

First Posted
February 14, 2018
Last Updated
November 29, 2021
Sponsor
University of Nottingham
Collaborators
Nottingham University Hospitals NHS Trust, National Institute for Health Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT03439917
Brief Title
Effects of Carnitine Supplementation on Liver and Muscle
Acronym
ECLIPSE
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 2, 2018 (Actual)
Primary Completion Date
August 30, 2020 (Actual)
Study Completion Date
November 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
Collaborators
Nottingham University Hospitals NHS Trust, National Institute for Health Research, United Kingdom

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease, Insulin Resistance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carnitine and Meal Replacement Drink
Arm Type
Experimental
Arm Description
2g L-carnitine tartrate consumed with a meal replacement milkshake (Slimfast, UK) twice a day for 24 weeks.
Arm Title
Placebo and Meal Replacement Drink
Arm Type
Placebo Comparator
Arm Description
2g Maltodextrin consumed with a meal replacement milkshake (Slimfast, UK) twice a day for 24 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
L-Carnitine tartrate
Intervention Description
2g L-Carnitine tartrate as a powder consumed twice a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Meal Replacement Drink
Other Intervention Name(s)
Slimfast
Intervention Description
325ml dairy-based meal replacement drink ('Slimfast' trademark of KSF Acquisition UK Ltd) consumed twice a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
2g Maltodextrin powder packaged to mimic carnitine powder consumed twice a day
Primary Outcome Measure Information:
Title
Intrahepatic triglyceride (IHTG) content
Description
IHTG measured by proton magnetic resonance spectroscopy
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
liver sensitivity to insulin
Description
suppression of glucose output from the liver during a 20 mU.m-2.min-1 hyperinsulinaemic euglycaemic clamp
Time Frame
24 weeks
Title
whole body insulin sensitivity
Description
whole body glucose uptake during a 50 mU.m-2.min-1 hyperinsulinaemic euglycaemic clamp
Time Frame
24 weeks
Title
Muscle lipid content
Description
lipid content of the vastus lateralis muscle measured by proton magnetic resonance spectroscopy
Time Frame
24 weeks
Title
Skeletal muscle sensitivity to insulin
Description
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
Time Frame
24 weeks
Title
whole body composition
Description
Fat and lean tissue mass assessment by dual energy X-ray absorptiometry
Time Frame
24 weeks
Title
Liver energy metabolism
Description
hepatic ATP flux assessed by 31-phosphorous magnetic resonance spectroscopy
Time Frame
24 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guru Aithal, MD, PhD
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
David Greenfield Human Physiology Unit
City
Nottingham
State/Province
Notts
ZIP/Postal Code
NG72UH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Carnitine Supplementation on Liver and Muscle

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