Hannover Medical School (MHH)
Hanover, Lower Saxony, 30625, Germany
NCT Number: NCT06634186
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Hanover, Lower Saxony, 30625, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The aim of the dietary intervention is the implementation of a fiber-enriched diet. Therefore, patients receive dietary counseling, supplemented with propionate, that functions as fiber-surrogate.
Time frame: The Liver Frailty Index will be measured at each study visit (Baseline, after 2 month and after 5 month)
Time frame: 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).
Time frame: Interleukin-6 will be measured at each study visit (Baseline, after 2 month and after 5 month)
Measurement of interleukin-6
Time frame: Stool samples will be collected at each study visit (Baseline, after 2 month and after 5 month)
Time frame: Questionnaires will be collected at each study visit (Baseline, after 2 month and after 5 month)
assessed with food-frequency-questionnaire (FFQ)
Time frame: 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)
Time frame: Each study visit (Baseline, after 2 month and after 5 month)
assessed with SF-36 questionnaire
Hannover Medical School
Other
The Impact of a Dietary Fiber Enriched Diet on Frailty, Sarcopenia, Systemic Inflammation and Microbiome Composition in Patients with Liver Cirrhosis
Acronym: ChainCirr
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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