The Acute Effects of Eucaloric and Hypocaloric Carbohydrate Restriction on Liver Fat Content and Metabolism in Obese Individuals

Study Overview
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Brief Summary
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The primary aim of this study is to investigate the acute changes in liver fat content in response to a fixed carbohydrate restriction (i.e. intake of 60g/day or 70g/day for women and men, respectively) in individuals with obesity. This will be performed both as 2 days of very low calorie diet (500 and 600 kcal/day for women and men, respectively) and 2 days of eucaloric low carbohydrate diet.

Official Title
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The Acute Effects of Eucaloric and Hypocaloric Carbohydrate Restriction on Liver Fat Content and Metabolism in Obese Individuals

Conditions
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NAFLD, Overweight and Obesity, Metabolic Syndrome, Diabetes

Intervention / Treatment
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* Other: Dietary composition of macronutrients and calories


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men (30-75 years) and postmenopausal women 45-75 years old Hba1c <48 mmol/mol without antidiabetic treatment Obese (BMI 27-40 kg/m2) Non smokers Exclusion Criteria: Anemia (hemoglobin <8 mmol/L for men and <7 mmol/L for women) TSH outside reference range Medication known to influence glucose metabolism or appetite regulation Contraindications for MR-scan: abdominal height exceed limitations of the MR-scanner, pacemaker or other electronic device implanted, implanted metal devices, severe claustrophobia Food allergies (including lactose and gluten intolerance), vegetarian/vegan diet or following specific dietary plans Alcohol consumptions >84/168 g/week (women/men) Strenuous activity level > 120 minutes per week >5 kg weight loss within the last three months or previous bariatric surgery High risk of fibrosis of the liver (estimated by FIB4 score > 3,25)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control Arm<br>2 days of eucaloric control diet prior to MRS estimating liver fat (control arm) | Other: Dietary composition of macronutrients and calories<br>* Carbohydrate restriction<br>|
| Experimental: Hypocaloric low carbohydrate<br>2 days of eucaloric control diet + 2 days of hypocaloric (500-600 kcal m/f) low carbohydrate diet prior to liver fat estimated by MRS and metabolic testday. | Other: Dietary composition of macronutrients and calories<br>* Carbohydrate restriction<br>|
| Experimental: Eucaloric low carbohydrate<br>2 days of eucaloric control diet + 2 days of eucaloric low carbohydrate diet prior to liver fat estimated by MRS and metabolic testday. | Other: Dietary composition of macronutrients and calories<br>* Carbohydrate restriction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is the 1H-Magnetic Resonance Spectroscopy (MRS) determined liver TG content. | We will compare MRS of liver TG after each of the two interventions (2 days of VLCD or 2 days of LC) with MRS liver TG obtained after 2 days of eucaloric conventional diet. | After 2 days completion of dietary intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes are fasting and postprandial plasma glucose, insulin, and plasma TG concentrations after 2 days VLCD or LC compared with 2 days of eucaloric conventional diet. |  | After 2 days completion of dietary intervention |