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

NCT03737071 | Active Not Recruiting

• 1 other identifier: HUS21372018
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatty Liver

Outcome Measures

Primary Outcomes (2)

• Change in hepatic triglyceride content

  Change in hepatic triglyceride content will be measured using 1H magnetic resonance spectroscopy (MRS).

  1 week

• Change in hepatic mitochondrial flux

  Change in the rate of hepatic mitochondrial flux (Vcs) will be assessed using 3-13C-lactate infusion.

  1 week

Secondary Outcomes (2)

• Change in beta-hydroxybutyrate production rate

  1 week

• Change in glucose production rate

  1 week

Study Arms (2)

Low Carbohydrate Diet

EXPERIMENTAL

Low Carbohydrate Diet

Behavioral: Low Carbohydrate Diet

Simple Calorie Restriction Diet

ACTIVE COMPARATOR

Simple Calorie Restriction Diet

Behavioral: Simple Calorie Restriction Diet

Interventions

Low Carbohydrate Diet BEHAVIORAL

Ketogenic dietary intervention

Low Carbohydrate Diet

Simple Calorie Restriction Diet BEHAVIORAL

Simple calorie restriction dietary intervention

Simple Calorie Restriction Diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70
• Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Biomedicum 2U

Helsinki, Uusimaa, 00290, Finland

Location

MeSH Terms

Conditions

Fatty Liver

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Panu Luukkonen

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Low Carbohydrate Diet versus Simple Calorie Restriction Diet

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 9, 2018
• Study Start: November 15, 2018
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)