The Acute Effects of Eucaloric and Hypocaloric Carbohydrate Restriction on Liver Fat Content and Metabolism in Obese Individuals
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Hvidovre University Hospital
- Enrollment
- 14
- Primary Endpoint
- The primary outcome is the 1H-Magnetic Resonance Spectroscopy (MRS) determined liver TG content.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
Control Arm
2 days of eucaloric control diet prior to MRS estimating liver fat (control arm)
Intervention: Dietary composition of macronutrients and calories (Other)
Hypocaloric low carbohydrate
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.
Intervention: Dietary composition of macronutrients and calories (Other)
Eucaloric low carbohydrate
2 days of eucaloric control diet + 2 days of eucaloric low carbohydrate diet prior to liver fat estimated by MRS and metabolic testday.
Intervention: Dietary composition of macronutrients and calories (Other)
Outcomes
Primary Outcomes
The primary outcome is the 1H-Magnetic Resonance Spectroscopy (MRS) determined liver TG content.
Time Frame: 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 Outcomes
- 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)
Investigators
Kirstine Nyvold Bojsen-Moeller
Principal investigator, MD, PhD Affiliation: Hvidovre University Hospital
Hvidovre University Hospital