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

Not Applicable

Completed

• Conditions: NAFLD; Metabolic Syndrome; Overweight and Obesity; Diabetes
• Interventions: Other: High Carb Low Fat Diet; Other: Low Carb High Fat Diet

• Registration Number: NCT04581421
• Lead Sponsor: Hvidovre University Hospital

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.

Study Timeline

• Study First Submitted: 2020-09-25
• Study First Submitted QC: 2020-10-05
• Study First Posted: 2020-10-09
• Study Start: 2020-12-03
• Primary Completion: 2022-06-15
• Study Completion: 2022-06-15
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High Carb first	Low Carb High Fat Diet	-
Low Carb first	Low Carb High Fat Diet	-
High Carb first	High Carb Low Fat Diet	-
Low Carb first	High Carb Low Fat Diet	-

Primary Outcome Measures

Name	Time	Method
Liverfat	(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

Name	Time	Method
Glycogen	(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
fasting blood triacylglycerol concentration	(Day 0 and Day 6 of the diet intervention)
fasting hepatic glucose output	(Day 0 and Day 6 of the diet intervention)	measured by Ra of glucose= (infusion rate of 6,6 2H2-glucose)/TTR
Insulin clearance determined during steady state insulin infusion	(Day 0 and Day 6 of the diet intervention)

Trial Locations

Locations (1)

Amalie London; 🇩🇰 Hvidovre, Denmark