The effects of FRUctose restrIcTion on LivEr SteatosiS; the FRUITLESS study

Completed

• Conditions: Non-alcoholic fatty liver disease (fatty liver); 10019654; 10000546; 10003216

• Registration Number: NL-OMON47128
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 68

Inclusion Criteria

- Age *18 years;
- BMI * 28;
- Fatty liver index * 60.

Exclusion Criteria

- Medical history of liver disease, such as viral and auto-immune hepatitis.
- (History of) excessive alcohol consumption (defined as > 2 units/day for women, and > 3 units/day for men);
- Use of glucose lowering drugs (including insulin);
- Recent illness;
- Pregnancy and/or lactation;
- Major change in weight and/or physical activity prior to the study;
- Contraindications for MRI (i.e. claustrophobia, heart pacemaker or other electronic devices implanted in the body, history of collapse or seizure);
- Inability to give informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Differences in intrahepatic triglyceride content between the intervention and<br /><br>control group.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Markers of cardiovascular risk * i.e. endothelial function, arterial stiffness,<br /><br>plasma lipids, plasma biomarkers of inflammation and endothelial function, and<br /><br>plasma advanced glycation end products * between the intervention and control<br /><br>group.</p><br>