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

Diabetes Clinical Trial

— LICARB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04581421
• Other study ID #: LICARB ID PhD010-19.
• Status: Completed
• Phase: N/A
• Start date: December 3, 2020
• Est. completion date: June 15, 2022

Study information

• Verified date: January 2024
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Metabolic Syndrome
• NAFLD
• Overweight
• Overweight and Obesity

Intervention

Other:
• High Carb Low Fat Diet
The participants will be randomized to a diet of low carb/ high fat og high carb/low fat
• Low Carb High Fat Diet
The participants will be randomized to a diet of low carb/ high fat og high carb/low fat

Locations

Country	Name	City	State
Denmark	Amalie London	Hvidovre

Sponsors (3)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Danish Research Centre for Magnetic Resonance, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liverfat	The effect of high-carbohydrate/low-fat vs low-carbohydrate/high-fat diet on change in MRS determined liver fat.	(MRS Day -1 (before intervention starts), Day 5 (after diet intervention is completed)
Secondary	Glycogen	effect of the low-carbohydrate/high-fat intake and high-carbohydrate/low-fat intake on hepatic glycogen content measured by 7T 13C-MRS	(MRS Day -1 (before intervention starts), Day 5 (after diet intervention is completed)
Secondary	fasting hepatic glucose output	measured by Ra of glucose= (infusion rate of 6,6 2H2-glucose)/TTR	(Day 0 and Day 6 of the diet intervention)
Secondary	fasting blood triacylglycerol concentration		(Day 0 and Day 6 of the diet intervention)
Secondary	Insulin clearance determined during steady state insulin infusion		(Day 0 and Day 6 of the diet intervention)