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Completed

NCT Number: NCT04041115

Effect of Non-alcoholic Beer in Cirrhosis

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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Key information

Conditions

Endothelial Dysfunction Atrophy Fibrosis Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional Status Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Quality of Life Sarcopenia Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-alcoholic beer

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.

Control

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.

Primary outcomes

  1. Nutritional status

    Time frame: 8 weeks

    improvement in impedance-derived phase angle (PhA)

  2. Endothelial function

    Time frame: 8 weeks

    improvement in flow-mediated dilation (brachial artery)

  3. Endothelial dysfunction

    Time frame: 8 weeks

    improvement in serum markers of endothelial function (v.gr. nitric oxide, NO; prostacyclin, PGI2, etc.)

  4. Quality of life questionnaire

    Time frame: 8 weeks

    Improvement in quality of life questionnaire CLDQ (chronic liver disease questionnaire)

  5. Changes in the heterogeneity of gut Microbiota

    Time frame: 8 weeks

    Changes in the heterogeneity of fecal microbiota in terms of bacterial diversity will be assessed

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Registry information

Official study title

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

Acronym: LFN-NAB

Important dates

Study start
2016
Primary completion
2018
Study completion
2022
First posted
Aug 1, 2019
Registry last updated
Sep 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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