The Effects of Low Carbohydrate Diet on Liver Fat Content and Mitochondrial Fluxes
Primary Purpose
Fatty Liver
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Low Carbohydrate Diet
Sponsored by
About this trial
This is an interventional basic science trial for Fatty Liver
Eligibility Criteria
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
Sites / Locations
- Biomedicum 2URecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Low Carbohydrate Diet
Arm Description
Low Carbohydrate Diet
Outcomes
Primary Outcome Measures
Change in hepatic triglyceride content
Change in hepatic triglyceride content will be measured using 1H magnetic resonance spectroscopy (MRS).
Change in hepatic mitochondrial flux
Change in the rate of hepatic mitochondrial flux (Vcs) will be assessed using 3-13C-lactate infusion.
Change in beta-hydroxybutyrate production rate
Change in the rate of beta-hydroxybutyrate production will be assessed using [13C4]β-hydroxybutyrate infusion.
Change in glucose production rate
Change in the rate of glucose production will be assessed using [2H7]glucose infusion.
Secondary Outcome Measures
Full Information
NCT ID
NCT03737071
First Posted
November 6, 2018
Last Updated
August 23, 2021
Sponsor
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03737071
Brief Title
The Effects of Low Carbohydrate Diet on Liver Fat Content and Mitochondrial Fluxes
Official Title
The Effects of Low Carbohydrate Diet on Liver Fat Content and Mitochondrial Fluxes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatty Liver
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low Carbohydrate Diet
Arm Type
Experimental
Arm Description
Low Carbohydrate Diet
Intervention Type
Behavioral
Intervention Name(s)
Low Carbohydrate Diet
Intervention Description
Ketogenic dietary intervention
Primary Outcome Measure Information:
Title
Change in hepatic triglyceride content
Description
Change in hepatic triglyceride content will be measured using 1H magnetic resonance spectroscopy (MRS).
Time Frame
1 week
Title
Change in hepatic mitochondrial flux
Description
Change in the rate of hepatic mitochondrial flux (Vcs) will be assessed using 3-13C-lactate infusion.
Time Frame
1 week
Title
Change in beta-hydroxybutyrate production rate
Description
Change in the rate of beta-hydroxybutyrate production will be assessed using [13C4]β-hydroxybutyrate infusion.
Time Frame
1 week
Title
Change in glucose production rate
Description
Change in the rate of glucose production will be assessed using [2H7]glucose infusion.
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Panu Luukkonen, MD, PhD
Phone
+358094711
Email
panu.luukkonen@helsinki.fi
Facility Information:
Facility Name
Biomedicum 2U
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00290
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aila Karioja-Kallio
Phone
+358094711
Email
ext-aila.karioja-kallio@hus.fi
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effects of Low Carbohydrate Diet on Liver Fat Content and Mitochondrial Fluxes
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