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Completed

NCT Number: NCT04581421

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Carb Low Fat Diet

Other

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

Low Carb High Fat Diet

Other

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Danish Research Centre for Magnetic Resonance
  • University of Copenhagen

Registry information

Acronym: LICARB

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 9, 2020
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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