Effect of Non-alcoholic Beer in Cirrhosis

Not Applicable

Completed

• Conditions: Endothelial Dysfunction; Nutritional Status; Quality of Life
• Interventions: Other: control; Dietary Supplement: Non-alcoholic beer

• Registration Number: NCT04041115
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief Summary

The implementation of nutritional strategies targeting several variables at once could benefit patients with cirrhosis. Non-alcoholic beer has different compounds derived from hops that exert antioxidant, anti-inflammatory and nutritional properties. The aim of this study is to evaluate the effect of diet + exercise and non-alcoholic beer on nutritional status, endothelial function and quality of life in patients with cirrhosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2018-12
• Status Verified: 2019-03
• Study First Submitted: 2019-04-26
• Study First Submitted QC: 2019-07-30
• Study First Posted: 2019-08-01
• Study Completion: 2022-08-15
• Last Update Submitted: 2022-08-31
• Last Update Posted: 2022-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Liver Cirrhosis of any aetiology (liver biopsy or a combination of clinical and biochemical variables plus evidence of portal hypertension); without decompensation during the past month; serum creatinine <1.5 mg%; able to attend the appointed visits and willing to participate in the study.

Exclusion Criteria

• Severe concomitant cardiopulmonary diseases; decompensated type 2 Diabetes Mellitus, insulin use or proliferative diabetic retinopathy; orthopedic or osteomuscular limitations; any type of cancer; primary sclerosing cholangitis and inflammatory bowel disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	control	personalized nutritional therapy + aerobic exercise
Non-alcoholic Beer	Non-alcoholic beer	non-alcoholic beer + personalized nutritional therapy + aerobic exercise

Primary Outcome Measures

Name	Time	Method
Quality of life questionnaire	8 weeks	Improvement in quality of life questionnaire CLDQ (chronic liver disease questionnaire)
Nutritional status	8 weeks	improvement in impedance-derived phase angle (PhA)
Endothelial dysfunction	8 weeks	improvement in serum markers of endothelial function (v.gr. nitric oxide, NO; prostacyclin, PGI2, etc.)
Changes in the heterogeneity of gut Microbiota	8 weeks	Changes in the heterogeneity of fecal microbiota in terms of bacterial diversity will be assessed
Endothelial function	8 weeks	improvement in flow-mediated dilation (brachial artery)