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Resolution of Liver Fat in Non-alcoholic Fatty Liver Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02558530
Recruitment Status : Completed
First Posted : September 24, 2015
Last Update Posted : April 12, 2022
Sahlgrenska University Hospital, Sweden
Göteborg University
Information provided by (Responsible Party):
Marja-Riitta Taskinen, Helsinki University Central Hospital

Brief Summary:
The major adverse health consequences of obesity occur only when non-alcoholic fatty liver disease (NAFLD) also develops. NAFLD is characterized by abnormal hepatic accumulation of triglycerides and other lipids. The first-line approach to NAFLD management is caloric restriction and weight loss, but these remain difficult to achieve. Little attention has been given to dietary carbohydrate restriction, despite recent reports showing that hepatic de novo lipogenesis, a process that converts dietary carbohydrates into fatty acids in the postprandial state, accounts for approximately 25% of liver triglyceride content in hyperinsulinemic subjects with NAFLD. For comparison, only 15% of the liver triglycerides were derived from dietary fatty acids in patients with NAFLD who had consumed a standardized 30% fat diet for four days before being assessed.

Condition or disease Intervention/treatment Phase
NAFLD Other: Low carbohydrate diet Not Applicable

Detailed Description:

To establish the time-course of hepatic fat loss in NAFLD subjects on a carbohydrate-restricted diet (<20 g/day), a serial assessments of liver fat during two week diet will be performed. Also, markers of lipid and insulin metabolism, liver function test and changes in gut microbiota during rapid metabolic improvement will be assessed.

The overall aim is to exploit this unique set of human material to determine the specific cellular and molecular pathways that are modified in the early stages of metabolic improvement and fatty liver regression.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rapid Resolution of Human Fatty Liver Disease, the Key to Obesity-related Morbidity and Mortality
Actual Study Start Date : January 2015
Actual Primary Completion Date : April 2021
Actual Study Completion Date : December 2021

Arm Intervention/treatment
Low carbohydrate diet
Isocaloric diet, <20 g carbohydrates per day
Other: Low carbohydrate diet
Isocaloric, carbohydrate restricted diet 14 days

Primary Outcome Measures :
  1. Liver fat percent by nuclear magnetic resonance imaging [ Time Frame: 14 days ]
    Liver fat percent measured by nuclear magnetic resonance imaging

Secondary Outcome Measures :
  1. De novo lipogenesis measured as Incorporation of new fatty acids (%) to very-low density lipoprotein triglycerides [ Time Frame: 14 days ]
  2. Gut microbiota measured as change in microbiome profile from baseline [ Time Frame: 14 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • increased liver fat above 5 % in magnetic resonance spectroscopy
  • body mass index 27-39.9 kg/m2

Exclusion Criteria:

  • liver cirrhosis
  • portal hypertension
  • chronic liver disease other than NAFLD
  • diabetes mellitus or other significant endocrine disease
  • any medication acting on nuclear hormone receptors or inducing liver enzymes or self-administration of supplements other than calcium or vitamins/trace elements
  • any significant cardiovascular co-morbidity
  • history of non-compliance
  • genotype (PNPLA3-MM and TM6SF2-TT) promoting liver fat accumulation

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): NCT02558530

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RPU Diabetes and Obesity, Biomedicum
Helsinki, Finland
Wllenberg Laboratory
Gothenburg, Sweden
Sponsors and Collaborators
Helsinki University Central Hospital
Sahlgrenska University Hospital, Sweden
Göteborg University
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Principal Investigator: Marja-Riitta Taskinen, Professor University of Helsinki
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marja-Riitta Taskinen, Professor, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02558530    
Other Study ID Numbers: Atkins
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: April 12, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Digestive System Diseases