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

Study Overview
=================
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.

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

Conditions
-----------------
NAFLD, Overweight and Obesity, Metabolic Syndrome, Diabetes

Intervention / Treatment
-----------------
* Other: High Carb Low Fat Diet
* Other: Low Carb High Fat Diet


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized diet intervention study in a cross over design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Carb first<br> | Other: High Carb Low Fat Diet<br>* The participants will be randomized to a diet of low carb/ high fat og high carb/low fat<br>Other: Low Carb High Fat Diet<br>* The participants will be randomized to a diet of low carb/ high fat og high carb/low fat<br>|
| Experimental: Low Carb first<br> | Other: High Carb Low Fat Diet<br>* The participants will be randomized to a diet of low carb/ high fat og high carb/low fat<br>Other: Low Carb High Fat Diet<br>* The participants will be randomized to a diet of low carb/ high fat og high carb/low fat<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liverfat | The effect of high-carbohydrate/low-fat vs low-carbohydrate/high-fat diet on change in MRS determined liver fat. | (MRS Day -1 (before intervention starts), Day 5 (after diet intervention is completed) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycogen | effect of the low-carbohydrate/high-fat intake and high-carbohydrate/low-fat intake on hepatic glycogen content measured by 7T 13C-MRS | (MRS Day -1 (before intervention starts), Day 5 (after diet intervention is completed) | 
| fasting hepatic glucose output | measured by Ra of glucose= (infusion rate of 6,6 2H2-glucose)/TTR | (Day 0 and Day 6 of the diet intervention) | 
| fasting blood triacylglycerol concentration |  | (Day 0 and Day 6 of the diet intervention) | 
| Insulin clearance determined during steady state insulin infusion |  | (Day 0 and Day 6 of the diet intervention) |