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Clinical Trials/NCT03737071
NCT03737071
Active, not recruiting
Not Applicable

The Effects of Low Carbohydrate Diet on Liver Fat Content and Mitochondrial Fluxes

Helsinki University Central Hospital1 site in 1 country10 target enrollmentNovember 15, 2018
ConditionsFatty Liver

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fatty Liver
Sponsor
Helsinki University Central Hospital
Enrollment
10
Locations
1
Primary Endpoint
Change in hepatic mitochondrial flux
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to examine whether a low carbohydrate diet as compared to simple calorie restriction decreases hepatic lipid content and changes hepatic mitochondrial flux in humans.

Detailed Description

In this study, the investigators will examine whether a low carbohydrate diet as compared to simple calorie restriction will change hepatic lipid content and mitochondrial flux in humans. Before and after a low carbohydrate diet and a simple calorie restriction intervention, rates of hepatic mitochondrial flux will be assessed using positional isotopomer analysis of 3-13C-lactate during a 3 hour basal period. Rates of whole body ketogenesis will be determined using \[13C4\]β-hydroxybutyrate, and whole body glucose metabolism will be measured using \[2H7\]glucose. Body composition will be determined with bioelectrical impedance; hepatic lipid content will be measured with MRS. Whole-body oxidation of lipids, carbohydrates and protein will be determined using indirect calorimetry.

Registry
clinicaltrials.gov
Start Date
November 15, 2018
End Date
August 2024
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Panu Luukkonen

MD, PhD

Helsinki University Central Hospital

Eligibility Criteria

Inclusion Criteria

  • Age 18-70
  • Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent

Exclusion Criteria

  • chronic liver disease other than NAFLD
  • chronic disease associated with hepatic steatosis such as diabetes mellitus
  • use of drugs known to affect hepatic steatosis
  • contraindications for MRI
  • pregnancy or nursing at the time of the study

Outcomes

Primary Outcomes

Change in hepatic mitochondrial flux

Time Frame: 1 week

Change in the rate of hepatic mitochondrial flux (Vcs) will be assessed using 3-13C-lactate infusion.

Change in hepatic triglyceride content

Time Frame: 1 week

Change in hepatic triglyceride content will be measured using 1H magnetic resonance spectroscopy (MRS).

Secondary Outcomes

  • Change in beta-hydroxybutyrate production rate(1 week)
  • Change in glucose production rate(1 week)

Study Sites (1)

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