Effects of Carnitine Supplementation on Liver and Muscle
NCT ID: NCT03439917
Last Updated: 2021-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2018-04-02
2021-11-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Carnitine and Meal Replacement Drink
2g L-carnitine tartrate consumed with a meal replacement milkshake (Slimfast, UK) twice a day for 24 weeks.
L-Carnitine tartrate
2g L-Carnitine tartrate as a powder consumed twice a day
Meal Replacement Drink
325ml dairy-based meal replacement drink ('Slimfast' trademark of KSF Acquisition UK Ltd) consumed twice a day
Placebo and Meal Replacement Drink
2g Maltodextrin consumed with a meal replacement milkshake (Slimfast, UK) twice a day for 24 weeks.
Meal Replacement Drink
325ml dairy-based meal replacement drink ('Slimfast' trademark of KSF Acquisition UK Ltd) consumed twice a day
Maltodextrin
2g Maltodextrin powder packaged to mimic carnitine powder consumed twice a day
Interventions
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L-Carnitine tartrate
2g L-Carnitine tartrate as a powder consumed twice a day
Meal Replacement Drink
325ml dairy-based meal replacement drink ('Slimfast' trademark of KSF Acquisition UK Ltd) consumed twice a day
Maltodextrin
2g Maltodextrin powder packaged to mimic carnitine powder consumed twice a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
50 Years
MALE
No
Sponsors
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Nottingham University Hospitals NHS Trust
OTHER
National Institute for Health Research, United Kingdom
OTHER_GOV
University of Nottingham
OTHER
Responsible Party
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Principal Investigators
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Guru Aithal, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham
Locations
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David Greenfield Human Physiology Unit
Nottingham, Notts, United Kingdom
Countries
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Other Identifiers
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17/EM/0441
Identifier Type: OTHER
Identifier Source: secondary_id
17086
Identifier Type: -
Identifier Source: org_study_id