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

H

Hvidovre University Hospital

Status

Completed

Conditions

Diabetes
Overweight and Obesity
NAFLD
Metabolic Syndrome

Treatments

Other: Low Carb High Fat Diet
Other: High Carb Low Fat Diet

Study type

Interventional

Funder types

Other

Identifiers

NCT04581421
LICARB ID PhD010-19.

Details and patient eligibility

About

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

Full 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.

Enrollment

12 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

12 participants in 2 patient groups

High Carb first
Experimental group
Treatment:
Other: Low Carb High Fat Diet
Other: High Carb Low Fat Diet
Low Carb first
Experimental group
Treatment:
Other: Low Carb High Fat Diet
Other: High Carb Low Fat Diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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