Skip to content

The Role of Dietary Carbohydrate and Fat Availability in the Regulation of Hepatic Lipid Content

The Role of Dietary Carbohydrate and Fat Availability in the Regulation of Hepatic Lipid Content

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04581421
Acronym
LICARB
Enrollment
12
Registered
2020-10-09
Start date
2020-12-03
Completion date
2022-06-15
Last updated
2024-01-23

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

Conditions

Diabetes, Metabolic Syndrome, NAFLD, Overweight and Obesity

Brief summary

The purpose of this study is to investigate dietary compositions effect on liverfat measured by magnetic resonance imaging.

Detailed description

Overweight but otherwise healthy men will be included in the study which is a randomized diet intervention study in a cross over design. The study involves 2 intervention periods of 5 days each, during which the participant ingests two different types of experimental diet. Participants will in randomized order (determined by block randomization) ingest a diet with low carbohydrate and high fat content, and a diet with high carbohydrate and low fat content.

Interventions

OTHERHigh Carb Low Fat Diet

The participants will be randomized to a diet of low carb/ high fat og high carb/low fat

OTHERLow Carb High Fat Diet

The participants will be randomized to a diet of low carb/ high fat og high carb/low fat

Sponsors

University of Copenhagen
CollaboratorOTHER
Danish Research Centre for Magnetic Resonance
CollaboratorOTHER
Hvidovre University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Randomized diet intervention study in a cross over design

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy men being 18-50 years old. * Overweight (BMI 25-35) * Low to moderate physical activity level, defined as ≤ 1 weekly session of aerobic exercise. * Non-smokers * No use of medicine

Exclusion criteria

* Fasting blood glucose indicating overt diabetes (≥7 mmol/l) * HbA1C \>48 mmol/mol * Fasting plasma triacylglycerol indicating dyslipidemia (≥2.2 mmol/l) * FIB-4 score \>1.45 * Contraindications for MR-scan: abdominal height exceed limitations of the MR-scanner, pacemaker or other electronic device implanted, implanted metal devices, severe claustrophobia.

Design outcomes

Primary

MeasureTime frameDescription
Liverfat(MRS Day -1 (before intervention starts), Day 5 (after diet intervention is completed)The effect of high-carbohydrate/low-fat vs low-carbohydrate/high-fat diet on change in MRS determined liver fat.

Secondary

MeasureTime frameDescription
Glycogen(MRS Day -1 (before intervention starts), Day 5 (after diet intervention is completed)effect of the low-carbohydrate/high-fat intake and high-carbohydrate/low-fat intake on hepatic glycogen content measured by 7T 13C-MRS
fasting hepatic glucose output(Day 0 and Day 6 of the diet intervention)measured by Ra of glucose= (infusion rate of 6,6 2H2-glucose)/TTR
fasting blood triacylglycerol concentration(Day 0 and Day 6 of the diet intervention)
Insulin clearance determined during steady state insulin infusion(Day 0 and Day 6 of the diet intervention)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026