Resolution of Liver Fat in Non-alcoholic Fatty Liver Disease

NAFLD Clinical Trial

Official title:

Rapid Resolution of Human Fatty Liver Disease, the Key to Obesity-related Morbidity and Mortality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02558530
• Other study ID #: Atkins
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 2021

Study information

• Verified date: April 2022
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• NAFLD

Intervention

Other:
• Low carbohydrate diet
Isocaloric, carbohydrate restricted diet 14 days

Locations

Country	Name	City	State
Finland	RPU Diabetes and Obesity, Biomedicum	Helsinki
Sweden	Wllenberg Laboratory	Gothenburg

Sponsors (3)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Göteborg University, Sahlgrenska University Hospital, Sweden

Countries where clinical trial is conducted

Finland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver fat percent by nuclear magnetic resonance imaging	Liver fat percent measured by nuclear magnetic resonance imaging	14 days
Secondary	De novo lipogenesis measured as Incorporation of new fatty acids (%) to very-low density lipoprotein triglycerides		14 days
Secondary	Gut microbiota measured as change in microbiome profile from baseline		14 days