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Effect of Non-alcoholic Beer in Cirrhosis (LFN-NAB)

Primary Purpose

Endothelial Dysfunction, Nutritional Status, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Non-alcoholic beer
control
Sponsored by
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endothelial Dysfunction focused on measuring cirrhosis, nutrition, sarcopenia, non-alcoholic beer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Control

    Non-alcoholic Beer

    Arm Description

    personalized nutritional therapy + aerobic exercise

    non-alcoholic beer + personalized nutritional therapy + aerobic exercise

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    April 26, 2019
    Last Updated
    August 31, 2022
    Sponsor
    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04041115
    Brief Title
    Effect of Non-alcoholic Beer in Cirrhosis
    Acronym
    LFN-NAB
    Official 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2016 (Actual)
    Primary Completion Date
    December 2018 (Actual)
    Study Completion Date
    August 15, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endothelial Dysfunction, Nutritional Status, Quality of Life
    Keywords
    cirrhosis, nutrition, sarcopenia, non-alcoholic beer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    42 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    personalized nutritional therapy + aerobic exercise
    Arm Title
    Non-alcoholic Beer
    Arm Type
    Active Comparator
    Arm Description
    non-alcoholic beer + personalized nutritional therapy + aerobic exercise
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Non-alcoholic beer
    Intervention Description
    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
    Other
    Intervention Name(s)
    control
    Intervention Description
    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 Outcome Measure Information:
    Title
    Nutritional status
    Description
    improvement in impedance-derived phase angle (PhA)
    Time Frame
    8 weeks
    Title
    Endothelial function
    Description
    improvement in flow-mediated dilation (brachial artery)
    Time Frame
    8 weeks
    Title
    Endothelial dysfunction
    Description
    improvement in serum markers of endothelial function (v.gr. nitric oxide, NO; prostacyclin, PGI2, etc.)
    Time Frame
    8 weeks
    Title
    Quality of life questionnaire
    Description
    Improvement in quality of life questionnaire CLDQ (chronic liver disease questionnaire)
    Time Frame
    8 weeks
    Title
    Changes in the heterogeneity of gut Microbiota
    Description
    Changes in the heterogeneity of fecal microbiota in terms of bacterial diversity will be assessed
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ricardo U. Macías-Rodríguez, M.D., Ph.D.
    Organizational Affiliation
    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Non-alcoholic Beer in Cirrhosis

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