A randomised, placebo-controlled, single blind, monocentric trial to investigate the influence of an artichoke leaf extract for the treatment of non-alcoholic fatty liver disease (NAFLD)

Not Applicable

• Conditions: E66.0; K76.0; Obesity due to excess calories; Fatty (change of) liver, not elsewhere classified

• Registration Number: DRKS00024706
• Lead Sponsor: niversität des Saarlandes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-11-02
• Study Start: 2024-04-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Indication and decision for bariatric surgery (laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass)
2. BMI > 35 kg / m²
3. Age: 18 - 65 years
4. Ability to understand and sign the patient information and informed consent form
5. Written declaration of consent

Exclusion Criteria

1. Alcohol consumption> 30 g / d in men,> 20 g / d in women
2. Other treatment for an existing non-alcoholic fatty liver disease
3. Allergy to artichokes and / or other cork family
4. Acute biliary diseases
5. Acute hepatitis (exception NASH)
6. Pacemaker
8. Pregnant and breastfeeding women
9. Participation in an interventional clinical study that interferes with the primary endpoint
10. Lack of patient compliance

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of the degree of steatosis before and after intervention defined by the Controlled Attenuation Parameter (CAP)

Secondary Outcome Measures

Name	Time	Method
1. Improvement of the fatty liver index after intervention compared to baseline<br>2. Reduction in liver size after intervention compared to baseline <br>3. Improvement of liver and blood values after intervention compared to basline<br>4. Relative weight loss (%) after intervention compared to baseline<br>5. Decrese in visceral fat after intervention compared to baseline<br>6. Analysis of the nutritional protocol<br>7. Surgeons assessment during surgery (fatty liver (y/n)<br>8. Safety and tolerability over the entire duration of the trial