The Impact of a Dietary Fiber Enriched Diet on the Outcome of Patients with Liver Cirrhosis

NCT06634186 | Enrolling By Invitation

• 1 other identifier: 10928_BO_S_2023
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change of phase angle (°)

  Phase angle will be measured at each study visit (Baseline, after 2 month and after 5 month)

• Change of systemic inflammation

  Interleukin-6 will be measured at each study visit (Baseline, after 2 month and after 5 month)

• 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)

• Change of body cell mass (BCM; kg)

  BCM will be measured at each study visit (Baseline, after 2 month and after 5 month)

Study Arms (1)

Dietary intervention

EXPERIMENTAL

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.

Dietary Supplement: Dietary intervention

Interventions

Dietary intervention DIETARY_SUPPLEMENT

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.

Dietary intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of legal age and with the ability to give informed consent
• Patients with liver cirrhosis and portal hypertension

You may not qualify if:

• Patients with transjugular intrahepatic portosystemic shunt (TIPS)
• significant immunosuppression
• malignant tumor
• underage

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Hannover Medical School (MHH)

Hanover, Lower Saxony, 30625, Germany

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: October 9, 2024
• Study Start: January 23, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

DE (1)