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

Hvidovre University Hospital

Status: Not yet enrolling

Conditions: Diabetes; Overweight and Obesity; NAFLD; Metabolic Syndrome

Treatments: Other: Dietary composition of macronutrients and calories

Study type: Interventional

Funder types: Other

Identifiers

NCT05643521

FixedCarb - H-22035189

Details and patient eligibility

About

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.

Enrollment: 14 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 3 patient groups

Control Arm

Experimental group

Description:

2 days of eucaloric control diet prior to MRS estimating liver fat (control arm)

Treatment:

Other: Dietary composition of macronutrients and calories

Hypocaloric low carbohydrate

Experimental group

Description:

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.

Treatment:

Other: Dietary composition of macronutrients and calories

Eucaloric low carbohydrate

Experimental group

Description:

2 days of eucaloric control diet + 2 days of eucaloric low carbohydrate diet prior to liver fat estimated by MRS and metabolic testday.

Treatment:

Other: Dietary composition of macronutrients and calories