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

Fatty Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03737071
• Other study ID #: HUS21372018
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2018
• Est. completion date: November 2022

Study information

• Verified date: August 2021
• Source: Helsinki University Central Hospital
• Contact: Panu Luukkonen, MD, PhD
• Phone: +358094711
• Email: panu.luukkonen[@]helsinki.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

In this study, the investigators will examine whether a low carbohydrate diet will change hepatic lipid content and mitochondrial flux in humans. Before and after a low carbohydrate diet 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: November 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver

Intervention

Behavioral:
• Low Carbohydrate Diet
Ketogenic dietary intervention

Locations

Country	Name	City	State
Finland	Biomedicum 2U	Helsinki	Uusimaa

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hepatic triglyceride content	Change in hepatic triglyceride content will be measured using 1H magnetic resonance spectroscopy (MRS).	1 week
Primary	Change in hepatic mitochondrial flux	Change in the rate of hepatic mitochondrial flux (Vcs) will be assessed using 3-13C-lactate infusion.	1 week
Primary	Change in beta-hydroxybutyrate production rate	Change in the rate of beta-hydroxybutyrate production will be assessed using [13C4]ß-hydroxybutyrate infusion.	1 week
Primary	Change in glucose production rate	Change in the rate of glucose production will be assessed using [2H7]glucose infusion.	1 week