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

• ClinicalTrials.gov Identifier: NCT04581421
• Recruitment Status: Not yet recruiting
• First Posted: October 9, 2020
• Last Update Posted: October 9, 2020
• Sponsor: Hvidovre University Hospital
• Collaborators: University of Copenhagen; Danish Research Centre for Magnetic Resonance
• Information provided by (Responsible Party): Kirstine Nyvold Bojsen-Moeller, Hvidovre University Hospital

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
NAFLD; Overweight and Obesity; Metabolic Syndrome; Diabetes	Other: High Carb Low Fat Diet; Other: Low Carb High Fat Diet	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Randomized diet intervention study in a cross over design
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: The Role of Dietary Carbohydrate and Fat Availability in the Regulation of Hepatic Lipid Content
• Estimated Study Start Date: October 21, 2020
• Estimated Primary Completion Date: August 2023
• Estimated Study Completion Date: August 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Liverfat [ Time Frame: (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 Outcome Measures :

1. Glycogen [ Time Frame: (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
2. fasting hepatic glucose output [ Time Frame: (Day 0 and Day 6 of the diet intervention) ]
   measured by Ra of glucose= (infusion rate of 6,6 2H2-glucose)/TTR
3. fasting blood triacylglycerol concentration [ Time Frame: (Day 0 and Day 6 of the diet intervention) ]
4. Insulin clearance determined during steady state insulin infusion [ Time Frame: (Day 0 and Day 6 of the diet intervention) ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Kirstine Nyvold Bojsen-Moeller, Principal investigator, MD, PhD, Hvidovre University Hospital
• ClinicalTrials.gov Identifier: NCT04581421
• Other Study ID Numbers: LICARB ID PhD010-19.
• First Posted: October 9, 2020
• Last Update Posted: October 9, 2020
• Last Verified: October 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Metabolic Syndrome; Overweight; Body Weight; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases