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

H

Helsinki University Central Hospital (HUCH)

Status

Active, not recruiting

Conditions

Fatty Liver

Treatments

Behavioral: Simple Calorie Restriction Diet
Behavioral: Low Carbohydrate Diet

Study type

Interventional

Funder types

Other

Identifiers

NCT03737071
HUS21372018

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

10 participants in 2 patient groups

Low Carbohydrate Diet
Experimental group
Description:
Low Carbohydrate Diet
Treatment:
Behavioral: Low Carbohydrate Diet
Simple Calorie Restriction Diet
Active Comparator group
Description:
Simple Calorie Restriction Diet
Treatment:
Behavioral: Simple Calorie Restriction Diet

Trial contacts and locations

1

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Central trial contact

Panu Luukkonen, MD, PhD

Data sourced from clinicaltrials.gov

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