NCT02558530

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

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

Study Start

First participant enrolled

January 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

6.3 years

First QC Date

September 21, 2015

Last Update Submit

April 11, 2022

Conditions

NAFLD

Outcome Measures

Primary Outcomes (1)

  • Liver fat percent by nuclear magnetic resonance imaging

    Liver fat percent measured by nuclear magnetic resonance imaging

    14 days

Secondary Outcomes (2)

  • De novo lipogenesis measured as Incorporation of new fatty acids (%) to very-low density lipoprotein triglycerides

    14 days

  • Gut microbiota measured as change in microbiome profile from baseline

    14 days

Study Arms (1)

Low carbohydrate diet

OTHER

Isocaloric diet, \<20 g carbohydrates per day

Other: Low carbohydrate diet

Interventions

Low carbohydrate dietOTHER

Isocaloric, carbohydrate restricted diet 14 days

Low carbohydrate diet

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

RPU Diabetes and Obesity, Biomedicum

Helsinki, Finland

Location

Wllenberg Laboratory

Gothenburg, Sweden

Location

Related Publications (1)

  • Mardinoglu A, Wu H, Bjornson E, Zhang C, Hakkarainen A, Rasanen SM, Lee S, Mancina RM, Bergentall M, Pietilainen KH, Soderlund S, Matikainen N, Stahlman M, Bergh PO, Adiels M, Piening BD, Graner M, Lundbom N, Williams KJ, Romeo S, Nielsen J, Snyder M, Uhlen M, Bergstrom G, Perkins R, Marschall HU, Backhed F, Taskinen MR, Boren J. An Integrated Understanding of the Rapid Metabolic Benefits of a Carbohydrate-Restricted Diet on Hepatic Steatosis in Humans. Cell Metab. 2018 Mar 6;27(3):559-571.e5. doi: 10.1016/j.cmet.2018.01.005. Epub 2018 Feb 15.

    PMID: 29456073DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Marja-Riitta Taskinen, Professor

    University of Helsinki

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 21, 2015

First Posted

September 24, 2015

Study Start

January 1, 2015

Primary Completion

April 1, 2021

Study Completion

December 1, 2021

Last Updated

April 12, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)SE(1)