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

Diabetes Clinical Trial

— FixedCarb  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05643521
• Other study ID #: FixedCarb - H-22035189
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: November 1, 2024

Study information

• Verified date: December 2022
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 14
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes
• Metabolic Syndrome
• NAFLD
• Overweight
• Overweight and Obesity

Intervention

Other:
• Dietary composition of macronutrients and calories
Carbohydrate restriction

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Nutrition Exercise and sports Copenhagen University, University of Copenhagen Danish Research Centre for Magnetic Resonance

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Explorative outcomes	Explorative outcomes are the effects of VLCD and LC on subsequent food intake in response to an ad libitum lunch meal.	After 2 days completion of dietary intervention
Primary	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	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