Effect of Non-alcoholic Beer in Cirrhosis

Quality of Life Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04041115
• Other study ID #: MICTLAN-2
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: August 15, 2022

Study information

• Verified date: March 2019
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 15, 2022
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Fibrosis
• Nutritional Status
• Quality of Life

Intervention

Dietary Supplement:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Outcome

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