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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-15

Study Completion Date

2024-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Acute Effects of Eucaloric and Hypocaloric Carbohydrate Restriction on Liver Fat Content and Metabolism in Obese Individuals

NCT05643521

NAFLD Overweight and Obesity Metabolic Syndrome +1 more

UNKNOWN NA

Effects of Low Fat Versus Low Carbohydrate Diets on Energy Metabolism

NCT03878108

Healthy Healthy Volunteers

COMPLETED NA

Combined Nutritional and Exercise Strategies to Reduce Liver Fat Content in Patients With Type 2 Diabetes

NCT01025856

Postprandial Lipids Metabolism Type 2 Diabetes

COMPLETED NA

Acute Metabolic Effects of Carbohydrate Restriction at Varying Energy Levels

NCT06387940

Healthy

COMPLETED NA

Effects of Dietary Manipulation on Metabolism in Healthy Adults

NCT00476125

Metabolic Regulation Fasting Ketogenic Diet

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fatty Liver

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Low Carbohydrate Diet versus Simple Calorie Restriction Diet

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low Carbohydrate Diet

Group Type EXPERIMENTAL

Low Carbohydrate Diet

Intervention Type BEHAVIORAL

Ketogenic dietary intervention

Simple Calorie Restriction Diet

Group Type ACTIVE_COMPARATOR

Simple Calorie Restriction Diet

Intervention Type BEHAVIORAL

Simple calorie restriction dietary intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Low Carbohydrate Diet

Ketogenic dietary intervention

Intervention Type BEHAVIORAL

Simple Calorie Restriction Diet

Simple calorie restriction dietary intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes