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

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status: Completed

Conditions: Nutritional Status; Endothelial Dysfunction; Quality of Life

Treatments: Other: control; Dietary Supplement: Non-alcoholic beer

Study type: Interventional

Funder types: Other

Identifiers

NCT04041115

MICTLAN-2

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Control

Active Comparator group

Description:

personalized nutritional therapy + aerobic exercise

Treatment:

Other: control

Non-alcoholic Beer

Active Comparator group

Description:

non-alcoholic beer + personalized nutritional therapy + aerobic exercise

Treatment:

Dietary Supplement: Non-alcoholic beer