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Effects of Carnitine Supplementation on Liver and Muscle (ECLIPSE)

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ClinicalTrials.gov Identifier: NCT03439917
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : June 6, 2019
Sponsor:
Collaborators:
Nottingham University Hospitals NHS Trust
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University of Nottingham

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.

Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Insulin Resistance Dietary Supplement: L-Carnitine tartrate Dietary Supplement: Meal Replacement Drink Dietary Supplement: Maltodextrin Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Carnitine Supplementation on Liver Steatosis, Insulin Sensitivity, Plasma Glucose Homeostasis, Skeletal Muscle Metabolism and Energetics: a Pilot Study
Actual Study Start Date : April 2, 2018
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Experimental: Carnitine and Meal Replacement Drink
2g L-carnitine tartrate consumed with a meal replacement milkshake (Slimfast, UK) twice a day for 24 weeks.
Dietary Supplement: L-Carnitine tartrate
2g L-Carnitine tartrate as a powder consumed twice a day

Dietary Supplement: Meal Replacement Drink
325ml dairy-based meal replacement drink ('Slimfast' trademark of KSF Acquisition UK Ltd) consumed twice a day
Other Name: Slimfast

Placebo Comparator: Placebo and Meal Replacement Drink
2g Maltodextrin consumed with a meal replacement milkshake (Slimfast, UK) twice a day for 24 weeks.
Dietary Supplement: Meal Replacement Drink
325ml dairy-based meal replacement drink ('Slimfast' trademark of KSF Acquisition UK Ltd) consumed twice a day
Other Name: Slimfast

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




Primary Outcome Measures :
  1. Intrahepatic triglyceride (IHTG) content [ Time Frame: 24 weeks ]
    IHTG measured by proton magnetic resonance spectroscopy


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439917


Contacts
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Contact: Prarthana Thiagarajan, MD +44 (0) 115 9709966 Prarthana.Thiagarajan@nottingham.ac.uk
Contact: Liz J Simpson, PhD +44 (0) 1158230128 liz.simpson@nottingham.ac.uk

Locations
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United Kingdom
David Greenfield Human Physiology Unit Recruiting
Nottingham, Notts, United Kingdom, NG72UH
Contact: Sara Brown    +44(0)115 8230434    sara.brown@nottingham.ac.uk   
Contact: Liz Simpson, PhD    +44(0)1158230128    liz.simpson@nottingham.ac.uk   
Sub-Investigator: Paul L Greenhaff, PhD         
Sub-Investigator: Ian A macdonald, PhD         
Sponsors and Collaborators
University of Nottingham
Nottingham University Hospitals NHS Trust
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Guru Aithal, MD, PhD University of Nottingham

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT03439917     History of Changes
Other Study ID Numbers: 17086
17/EM/0441 ( Other Identifier: REC Reference )
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Digestive System Diseases