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

Primary Purpose

NAFLD, Overweight and Obesity, Metabolic Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High Carb Low Fat Diet
Low Carb High Fat Diet
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for NAFLD

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    High Carb first

    Low Carb first

    Arm Description

    Outcomes

    Primary Outcome Measures

    Liverfat
    The effect of high-carbohydrate/low-fat vs low-carbohydrate/high-fat diet on change in MRS determined liver fat.

    Secondary Outcome Measures

    Glycogen
    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
    measured by Ra of glucose= (infusion rate of 6,6 2H2-glucose)/TTR
    fasting blood triacylglycerol concentration
    Insulin clearance determined during steady state insulin infusion

    Full Information

    First Posted
    September 25, 2020
    Last Updated
    October 5, 2020
    Sponsor
    Hvidovre University Hospital
    Collaborators
    University of Copenhagen, Danish Research Centre for Magnetic Resonance
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04581421
    Brief Title
    The Role of Dietary Carbohydrate and Fat Availability in the Regulation of Hepatic Lipid Content
    Acronym
    LICARB
    Official Title
    The Role of Dietary Carbohydrate and Fat Availability in the Regulation of Hepatic Lipid Content
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 21, 2020 (Anticipated)
    Primary Completion Date
    August 2023 (Anticipated)
    Study Completion Date
    August 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hvidovre University Hospital
    Collaborators
    University of Copenhagen, Danish Research Centre for Magnetic Resonance

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    NAFLD, Overweight and Obesity, Metabolic Syndrome, Diabetes

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Randomized diet intervention study in a cross over design
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    14 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    High Carb first
    Arm Type
    Experimental
    Arm Title
    Low Carb first
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    High Carb Low Fat Diet
    Intervention Description
    The participants will be randomized to a diet of low carb/ high fat og high carb/low fat
    Intervention Type
    Other
    Intervention Name(s)
    Low Carb High Fat Diet
    Intervention Description
    The participants will be randomized to a diet of low carb/ high fat og high carb/low fat
    Primary Outcome Measure Information:
    Title
    Liverfat
    Description
    The effect of high-carbohydrate/low-fat vs low-carbohydrate/high-fat diet on change in MRS determined liver fat.
    Time Frame
    (MRS Day -1 (before intervention starts), Day 5 (after diet intervention is completed)
    Secondary Outcome Measure Information:
    Title
    Glycogen
    Description
    effect of the low-carbohydrate/high-fat intake and high-carbohydrate/low-fat intake on hepatic glycogen content measured by 7T 13C-MRS
    Time Frame
    (MRS Day -1 (before intervention starts), Day 5 (after diet intervention is completed)
    Title
    fasting hepatic glucose output
    Description
    measured by Ra of glucose= (infusion rate of 6,6 2H2-glucose)/TTR
    Time Frame
    (Day 0 and Day 6 of the diet intervention)
    Title
    fasting blood triacylglycerol concentration
    Time Frame
    (Day 0 and Day 6 of the diet intervention)
    Title
    Insulin clearance determined during steady state insulin infusion
    Time Frame
    (Day 0 and Day 6 of the diet intervention)

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.

    12. IPD Sharing Statement

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

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