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Active, Not Recruiting

NCT Number: NCT03737071

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Fatty Liver Digestive System Diseases Liver Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biomedicum 2U

Helsinki, Uusimaa, 00290, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

low carbohydrate diet

Behavioral

Ketogenic dietary intervention

Simple Calorie Restriction Diet

Behavioral

Simple calorie restriction dietary intervention

Primary outcomes

  1. Change in hepatic triglyceride content

    Time frame: 1 week

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

  2. 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.

Secondary outcomes

  1. Change in beta-hydroxybutyrate production rate

    Time frame: 1 week

    Change in the rate of beta-hydroxybutyrate production will be assessed using [13C4]β-hydroxybutyrate infusion.

  2. Change in glucose production rate

    Time frame: 1 week

    Change in the rate of glucose production will be assessed using [2H7]glucose infusion.

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Nov 9, 2018
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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