E66.0 K76.0
Conditions
Interventions
Group 1: Six weeks (42 days ± 5) daily intake of an artichoke leaf extract (2600 mg). Three weeks (21 days ± 5) before surgery, additional hypocaloric, low-carbohydrate and protein-rich crash diet acc
Sponsors
Universität des Saarlandes
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the degree of steatosis before and after intervention defined by the Controlled Attenuation Parameter (CAP) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement of the fatty liver index after intervention compared to baseline 2. Reduction in liver size after intervention compared to baseline 3. Improvement of liver and blood values after intervention compared to basline 4. Relative weight loss (%) after intervention compared to baseline 5. Decrese in visceral fat after intervention compared to baseline 6. Analysis of the nutritional protocol 7. Surgeons assessment during surgery (fatty liver (y/n) 8. Safety and tolerability over the entire duration of the trial | — |
Countries
Germany
Contacts
Public ContactEvelyn Marth
Universität des Saarlandes
Outcome results
None listed