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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03737071
Enrollment
10
Registered
2018-11-09
Start date
2018-11-15
Completion date
2024-08-31
Last updated
2024-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatty Liver

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.

Interventions

BEHAVIORALLow Carbohydrate Diet

Ketogenic dietary intervention

BEHAVIORALSimple Calorie Restriction Diet

Simple calorie restriction dietary intervention

Sponsors

Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Low Carbohydrate Diet versus Simple Calorie Restriction Diet

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in hepatic triglyceride content1 weekChange in hepatic triglyceride content will be measured using 1H magnetic resonance spectroscopy (MRS).
Change in hepatic mitochondrial flux1 weekChange in the rate of hepatic mitochondrial flux (Vcs) will be assessed using 3-13C-lactate infusion.

Secondary

MeasureTime frameDescription
Change in beta-hydroxybutyrate production rate1 weekChange in the rate of beta-hydroxybutyrate production will be assessed using \[13C4\]β-hydroxybutyrate infusion.
Change in glucose production rate1 weekChange in the rate of glucose production will be assessed using \[2H7\]glucose infusion.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026