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

Not Applicable

Active, not recruiting

• Conditions: Fatty Liver
• Interventions: Behavioral: Low Carbohydrate Diet; Behavioral: Simple Calorie Restriction Diet

• Registration Number: NCT03737071
• Lead Sponsor: Helsinki University Central Hospital

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.

Study Timeline

• Study First Submitted: 2018-11-06
• Study First Submitted QC: 2018-11-07
• Study First Posted: 2018-11-09
• Study Start: 2018-11-15
• Status Verified: 2024-07
• Primary Completion: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low Carbohydrate Diet	Low Carbohydrate Diet	Low Carbohydrate Diet
Simple Calorie Restriction Diet	Simple Calorie Restriction Diet	Simple Calorie Restriction Diet

Primary Outcome Measures

Name	Time	Method
Change in hepatic mitochondrial flux	1 week	Change in the rate of hepatic mitochondrial flux (Vcs) will be assessed using 3-13C-lactate infusion.
Change in hepatic triglyceride content	1 week	Change in hepatic triglyceride content will be measured using 1H magnetic resonance spectroscopy (MRS).

Secondary Outcome Measures

Name	Time	Method
Change in beta-hydroxybutyrate production rate	1 week	Change in the rate of beta-hydroxybutyrate production will be assessed using \[13C4\]β-hydroxybutyrate infusion.
Change in glucose production rate	1 week	Change in the rate of glucose production will be assessed using \[2H7\]glucose infusion.

Trial Locations

Locations (1)

Biomedicum 2U; 🇫🇮 Helsinki, Uusimaa, Finland