Effect of Non-alcoholic Beer in Cirrhosis

NCT04041115 | Completed DMC

• 1 other identifier: MICTLAN-2
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endothelial Dysfunction; Nutritional Status; Quality of Life

Keywords

cirrhosis; nutrition; sarcopenia; non-alcoholic beer

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Control

ACTIVE COMPARATOR

personalized nutritional therapy + aerobic exercise

Other: control

Non-alcoholic Beer

ACTIVE COMPARATOR

non-alcoholic beer + personalized nutritional therapy + aerobic exercise

Dietary Supplement: Non-alcoholic beer

Interventions

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.

Non-alcoholic Beer

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.

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

MeSH Terms

Conditions

Fibrosis; Sarcopenia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Ricardo U. Macías-Rodríguez, M.D., Ph.D.

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: August 1, 2019
• Study Start: January 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: August 15, 2022
• Last Updated: September 1, 2022

Record last verified: 2019-03