Non-Alcoholic Fatty Liver DiseaseECLIPSENCT03439917
Effects of Carnitine Supplementation on Liver and Muscle
A study testing L-Carnitine tartrate, Meal Replacement Drink and Maltodextrin in people with Non-Alcoholic Fatty Liver Disease and Insulin Resistance, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Insulin Resistance
- What is being tested?
- L-Carnitine tartrate, Meal Replacement Drink and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Apr 2018to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
David Greenfield Human Physiology Unit
Nottingham, Notts, NG72UH
About this study
Official title: Effect of Carnitine Supplementation on Liver Steatosis, Insulin Sensitivity, Plasma Glucose Homeostasis, Skeletal Muscle Metabolism and Energetics: a Pilot Study
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.
Read the 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
- Being tested
- L-Carnitine tartrate, Meal Replacement Drink, Maltodextrin
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-Carnitine tartrateDietary supplement
2g L-Carnitine tartrate as a powder consumed twice a day
Meal Replacement DrinkDietary supplement
Also called Slimfast
325ml dairy-based meal replacement drink ('Slimfast' trademark of KSF Acquisition UK Ltd) consumed twice a day
MaltodextrinDietary supplement
2g Maltodextrin powder packaged to mimic carnitine powder consumed twice a day
| Study group | Role | What they receive |
|---|---|---|
| Carnitine and Meal Replacement Drink | Experimental | 2g L-carnitine tartrate consumed with a meal replacement milkshake (Slimfast, UK) twice a day for 24 weeks. Receives: Dietary Supplement: L-Carnitine tartrate; Dietary Supplement: Meal Replacement Drink |
| Placebo and Meal Replacement Drink | Placebo comparator | 2g Maltodextrin consumed with a meal replacement milkshake (Slimfast, UK) twice a day for 24 weeks. Receives: Dietary Supplement: Meal Replacement Drink; Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrahepatic triglyceride (IHTG) content
IHTG measured by proton magnetic resonance spectroscopy
Measured: 24 weeks
Secondary outcomes (6)
liver sensitivity to insulin
suppression of glucose output from the liver during a 20 mU.m-2.min-1 hyperinsulinaemic euglycaemic clamp
Measured: 24 weeks
whole body insulin sensitivity
whole body glucose uptake during a 50 mU.m-2.min-1 hyperinsulinaemic euglycaemic clamp
Measured: 24 weeks
Muscle lipid content
lipid content of the vastus lateralis muscle measured by proton magnetic resonance spectroscopy
Measured: 24 weeks
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
Measured: 24 weeks
whole body composition
Fat and lean tissue mass assessment by dual energy X-ray absorptiometry
Measured: 24 weeks
Liver energy metabolism
hepatic ATP flux assessed by 31-phosphorous magnetic resonance spectroscopy
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start2 Apr 2018
- Primary completion30 Aug 2020
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Guru Aithal, MD, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439917
- Sponsor's protocol ID
- 17086
- Other IDs
- 17/EM/0441
- Acronym
- ECLIPSE
- Status last verified
- Nov 2021
- First submitted
- 14 Feb 2018
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Carnitine Supplementation on Liver Steatosis, Insulin Sensitivity, Plasma Glucose Homeostasis, Skeletal Muscle Metabolism and Energetics: a Pilot Study
- ClinicalTrials.gov ID
- NCT03439917
- Acronym / sponsor ID
- ECLIPSE / 17086
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust, National Institute for Health Research, United Kingdom
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 20 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carnitine and Meal Replacement Drink | Experimental | Dietary Supplement: L-Carnitine tartrate, Dietary Supplement: Meal Replacement Drink2g L-carnitine tartrate consumed with a meal replacement milkshake (Slimfast, UK) twice a day for 24 weeks. |
| Placebo and Meal Replacement Drink | Placebo comparator | Dietary Supplement: Meal Replacement Drink, Dietary Supplement: Maltodextrin2g Maltodextrin consumed with a meal replacement milkshake (Slimfast, UK) twice a day for 24 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Known history of cardiovascular disease
- Known diabetes mellitus
- Known psychiatric comorbidity
- Chronic kidney disease
- Surgery within 6 months prior to start of study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-Carnitine tartrate2g L-Carnitine tartrate as a powder consumed twice a day | Dietary supplement | Carnitine and Meal Replacement Drink |
| Meal Replacement DrinkAlso: Slimfast325ml dairy-based meal replacement drink ('Slimfast' trademark of KSF Acquisition UK Ltd) consumed twice a day | Dietary supplement | Carnitine and Meal Replacement Drink, Placebo and Meal Replacement Drink |
| Maltodextrin2g Maltodextrin powder packaged to mimic carnitine powder consumed twice a day | Dietary supplement | Placebo and Meal Replacement Drink |
Primary outcome
Intrahepatic triglyceride (IHTG) content
Time frame: 24 weeks
IHTG measured by proton magnetic resonance spectroscopy
6 secondary outcomes
liver sensitivity to insulin
Time frame: 24 weeks
whole body insulin sensitivity
Time frame: 24 weeks
Muscle lipid content
Time frame: 24 weeks
Skeletal muscle sensitivity to insulin
Time frame: 24 weeks
whole body composition
Time frame: 24 weeks
Liver energy metabolism
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guru Aithal, MD, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-Carnitine tartrate, Meal Replacement Drink and Maltodextrin in people with Non-Alcoholic Fatty Liver Disease and Insulin Resistance, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrahepatic triglyceride (IHTG) content (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.