Diabetes, Metabolic Syndrome, NAFLD, Overweight and Obesity
Conditions
Brief summary
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.
Interventions
OTHERDietary composition of macronutrients and calories
Carbohydrate restriction
Sponsors
University of Copenhagen Danish Research Centre for Magnetic Resonance
Nutrition Exercise and sports Copenhagen University
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Crossover Assignment Randomized diet intervention study in a cross over design
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome is the 1H-Magnetic Resonance Spectroscopy (MRS) determined liver TG content. | After 2 days completion of dietary intervention | 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. |
Secondary
| Measure | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Explorative outcomes | After 2 days completion of dietary intervention | Explorative outcomes are the effects of VLCD and LC on subsequent food intake in response to an ad libitum lunch meal. |
Outcome results
None listed