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

Not Applicable

Not yet recruiting

• Conditions: Overweight and Obesity; NAFLD; Metabolic Syndrome; Diabetes
• Interventions: Other: Dietary composition of macronutrients and calories

• Registration Number: NCT05643521
• Lead Sponsor: Hvidovre University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-22
• Status Verified: 2022-12
• Study Start: 2022-12-01
• Study First Submitted QC: 2022-12-01
• Last Update Submitted: 2022-12-01
• Study First Posted: 2022-12-08
• Last Update Posted: 2022-12-08
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 14

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hypocaloric low carbohydrate	Dietary composition of macronutrients and calories	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.
Control Arm	Dietary composition of macronutrients and calories	2 days of eucaloric control diet prior to MRS estimating liver fat (control arm)
Eucaloric low carbohydrate	Dietary composition of macronutrients and calories	2 days of eucaloric control diet + 2 days of eucaloric low carbohydrate diet prior to liver fat estimated by MRS and metabolic testday.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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