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

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

Study Overview

• Status: Completed
• Conditions: Diabetes; Metabolic Syndrome; NAFLD; Overweight and Obesity
• Intervention / Treatment: Other: High Carb Low Fat Diet; Other: Low Carb High Fat Diet

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark
    • Amalie London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Carb first	Other: High Carb Low Fat Diet; The participants will be randomized to a diet of low carb/ high fat og high carb/low fat; Other: Low Carb High Fat Diet; The participants will be randomized to a diet of low carb/ high fat og high carb/low fat
Experimental: Low Carb first	Other: High Carb Low Fat Diet; The participants will be randomized to a diet of low carb/ high fat og high carb/low fat; Other: Low Carb High Fat Diet; The participants will be randomized to a diet of low carb/ high fat og high carb/low fat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Collaborators: University of Copenhagen; Danish Research Centre for Magnetic Resonance

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2020
• Primary Completion (Actual): June 15, 2022
• Study Completion (Actual): June 15, 2022

Study Registration Dates

• First Submitted: September 25, 2020
• First Submitted That Met QC Criteria: October 5, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome; Overweight
• Other Study ID Numbers: LICARB ID PhD010-19.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No