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

July 23, 2024 updated by: Panu Luukkonen, Helsinki University Central Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00290
        • Biomedicum 2U

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Carbohydrate Diet
Behavioral: Low Carbohydrate Diet
Ketogenic dietary intervention
Active Comparator: Simple Calorie Restriction Diet
Behavioral: Simple Calorie Restriction Diet
Simple calorie restriction dietary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in hepatic triglyceride content
Time Frame: 1 week
Change in hepatic triglyceride content will be measured using 1H magnetic resonance spectroscopy (MRS).
1 week
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.
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week
Change in glucose production rate
Time Frame: 1 week
Change in the rate of glucose production will be assessed using [2H7]glucose infusion.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Principal Investigator: Panu Luukkonen, Helsinki University Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2018

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

November 6, 2018

First Submitted That Met QC Criteria

November 7, 2018

First Posted (Actual)

November 9, 2018

Study Record Updates

Last Update Posted (Actual)

July 24, 2024

Last Update Submitted That Met QC Criteria

July 23, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUS21372018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will be shared as much as our ethics permission and the GDPR regulations of the European Union allow

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fatty Liver

Clinical Trials on Low Carbohydrate Diet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe