Effect of Non-alcoholic Beer in Cirrhosis

Study Overview
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Brief Summary
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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.

Official Title
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Effect of a Multifactorial Intervention (Non-alcoholic Beer, Diet and Exercise) on Endothelial Function, Nutritional Status and Quality of Life in Patients With Cirrhosis

Conditions
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Endothelial Dysfunction, Nutritional Status, Quality of Life

Intervention / Treatment
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* Dietary Supplement: Non-alcoholic beer
* Other: control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>personalized nutritional therapy + aerobic exercise | Other: control<br>* Treatment consisted of 330ml of water, plus an individualized dietary program and an exercise program with a pedometer-based bracelet to reach at least 5000 steps/day during 2 + 8 weeks.<br>|
| Active Comparator: Non-alcoholic Beer<br>non-alcoholic beer + personalized nutritional therapy + aerobic exercise | Dietary Supplement: Non-alcoholic beer<br>* Treatment consisted of 330ml non-alcoholic beer per day, plus an individualized dietary program and an exercise program with a pedometer-based bracelet to reach at least 5000 steps/day during 2 + 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cirrhosis, nutrition, sarcopenia, non-alcoholic beer