Effect of Non-alcoholic Beer in Cirrhosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2022-08-15

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.

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Detailed Description

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Conditions

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Endothelial Dysfunction Nutritional Status Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

personalized nutritional therapy + aerobic exercise

Group Type ACTIVE_COMPARATOR

control

Intervention Type OTHER

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.

Non-alcoholic Beer

non-alcoholic beer + personalized nutritional therapy + aerobic exercise

Group Type ACTIVE_COMPARATOR

Non-alcoholic beer

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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Non-alcoholic beer

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.

Intervention Type DIETARY_SUPPLEMENT

control

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.

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No