Overview

This trial is active, not recruiting.

Condition nafld
Treatment low carbohydrate diet
Sponsor Helsinki University Central Hospital
Collaborator Sahlgrenska University Hospital, Sweden
Start date January 2015
End date November 2015
Trial size 20 participants
Trial identifier NCT02558530, Atkins

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Isocaloric diet, <20 g carbohydrates per day
low carbohydrate diet
Isocaloric, carbohydrate restricted diet 14 days

Primary Outcomes

Measure
Liver fat percent by nuclear magnetic resonance imaging
time frame: 14 days

Secondary Outcomes

Measure
De novo lipogenesis measured as Incorporation of new fatty acids (%) to very-low density lipoprotein triglycerides
time frame: 14 days
Gut microbiota measured as change in microbiome profile from baseline
time frame: 14 days

Eligibility Criteria

Male or female participants from 20 years up to 70 years old.

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

Additional Information

Official title Rapid Resolution of Human Fatty Liver Disease, the Key to Obesity-related Morbidity and Mortality
Principal investigator Marja-Riitta Taskinen, Professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Helsinki University Central Hospital.