NCT03439917

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 2, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

November 30, 2021

Status Verified

November 1, 2021

Enrollment Period

2.4 years

First QC Date

February 14, 2018

Last Update Submit

November 29, 2021

Conditions

Non-Alcoholic Fatty Liver DiseaseInsulin Resistance

Outcome Measures

Primary Outcomes (1)

  • Intrahepatic triglyceride (IHTG) content

    IHTG measured by proton magnetic resonance spectroscopy

    24 weeks

Secondary Outcomes (6)

  • liver sensitivity to insulin

    24 weeks

  • whole body insulin sensitivity

    24 weeks

  • Muscle lipid content

    24 weeks

  • Skeletal muscle sensitivity to insulin

    24 weeks

  • whole body composition

    24 weeks

  • +1 more secondary outcomes

Study Arms (2)

Carnitine and Meal Replacement Drink

EXPERIMENTAL

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

Dietary Supplement: L-Carnitine tartrateDietary 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.

Dietary Supplement: Meal Replacement DrinkDietary Supplement: Maltodextrin

Interventions

L-Carnitine tartrateDIETARY_SUPPLEMENT

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

Carnitine and Meal Replacement Drink
Meal Replacement DrinkDIETARY_SUPPLEMENT

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

Also known as: Slimfast
Carnitine and Meal Replacement DrinkPlacebo and Meal Replacement Drink
MaltodextrinDIETARY_SUPPLEMENT

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

Placebo and Meal Replacement Drink

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

David Greenfield Human Physiology Unit

Nottingham, Notts, NG72UH, United Kingdom

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseInsulin Resistance

Interventions

slif protein, Drosophilamaltodextrin

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Guru Aithal, MD, PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2018

First Posted

February 20, 2018

Study Start

April 2, 2018

Primary Completion

August 30, 2020

Study Completion

November 1, 2021

Last Updated

November 30, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)