The Impact of a Dietary Fiber Enriched Diet on the Outcome of Patients with Liver Cirrhosis
- Conditions
- Liver Cirrhosis
- Interventions
- Dietary Supplement: Dietary intervention
- Registration Number
- NCT06634186
- Lead Sponsor
- Hannover Medical School
- Brief Summary
The goal of this dietary intervention is to study the impact of a dietary fiber enriched diet on the intestinal dysbiosis, systemic inflammation and cirrhosis-related complications in patients with liver cirrhosis.
Therefore, our aim is to investigate the impact of a dietary fiber enriched diet on
* frailty and sarcopenia
* systemic inflammation
* microbiome composition
* quality of life and the composition of patients diet.
Participants receive a dietary counselling and will be asked to increase their dietary fiber intake. As malnutrition is a common complication in cirrhosis and patients with advanced liver disease often show a disability to meet their daily food-requirements, the recommended intake of 30 gram dietary fibers per day is unlikely in this group of patients. Therefore, the fiber-enriched diet will be supplemented by the physiological short-chain-fatty-acid propionate, as a fiber-surrogate.
- Detailed Description
The disease course of liver cirrhosis is associated with a progressing dysbiosis of the intestinal microbiome and systemic inflammation, that leads to the development of cirrhosis-associated immune dysfunction (CAID). In healthy individuals, the microbiome uses orally incorporated dietary fibers for the production of short-chain-fatty-acids (SCFA). One of these physiological short-chain-fatty acids is propionate. SCFA´s are essential for a maintained integrity of the intestinal barrier and promote anti-inflammatory effects. Due to a reduction of symbiotic gut bacteria and an elevated number of potentially pathogenic microbes in cirrhosis, diminished levels of SCFA can be observed in this group of patients. Consequently, the permeability of the gut barrier increases and a bacterial translocation results. This translocation is a main driver of systemic inflammation and is linked to a higher likelihood for infections, such as spontaneous bacterial peritonitis (SBP). Furthermore, systemic inflammation promotes the degradation of skeleton muscles (sarcopenia) and frailty. Both are associated with a poor prognosis in cirrhosis. However, the impact of an adapted diet, that intends to normalize the intestinal SCFA-levels, on the clinical outcome of patients with advanced liver disease, needs to be further evaluated.
Therefore, the included patients receive dietary counseling, supplemented with propionate, that functions as fiber-surrogate. The dietary-intervention will last for a period of two months.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 38
- Patients of legal age and with the ability to give informed consent
- Patients with liver cirrhosis and portal hypertension
- Patients with transjugular intrahepatic portosystemic shunt (TIPS)
- significant immunosuppression
- malignant tumor
- underage
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dietary intervention Dietary intervention The studied patients will receive a dietary intervention. This intervention includes a dietary counselling, that enables our patients to establish a fiber-enriched diet. This adapted diet will be supplemented by the short-chain-fatty-acid propionate, that functions as fiber-surrogate.
- Primary Outcome Measures
Name Time Method Change of the Liver Frailty Index The Liver Frailty Index will be measured at each study visit (Baseline, after 2 month and after 5 month)
- Secondary Outcome Measures
Name Time Method Change of phase angle (°) Phase angle will be measured at each study visit (Baseline, after 2 month and after 5 month) The phase angle will be measured with body impedance analysis (BIA).
Change of systemic inflammation Interleukin-6 will be measured at each study visit (Baseline, after 2 month and after 5 month) Measurement of interleukin-6
Change of microbiome composition Stool samples will be collected at each study visit (Baseline, after 2 month and after 5 month) Change of diet composition Questionnaires will be collected at each study visit (Baseline, after 2 month and after 5 month) assessed with food-frequency-questionnaire (FFQ)
Change of body cell mass (BCM; kg) BCM will be measured at each study visit (Baseline, after 2 month and after 5 month) Body cell mass will be measured with body impedance analysis (BIA)
Improvement of quality of life Each study visit (Baseline, after 2 month and after 5 month) assessed with SF-36 questionnaire
Trial Locations
- Locations (1)
Hannover Medical School (MHH)
🇩🇪Hannover, Lower Saxony, Germany