Endothelial Dysfunction, Nutritional Status, Quality of Life
Conditions
Keywords
cirrhosis, nutrition, sarcopenia, non-alcoholic beer
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.
Interventions
DIETARY_SUPPLEMENTNon-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.
OTHERcontrol
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.
Sponsors
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nutritional status | 8 weeks | improvement in impedance-derived phase angle (PhA) |
| Endothelial function | 8 weeks | improvement in flow-mediated dilation (brachial artery) |
| Endothelial dysfunction | 8 weeks | improvement in serum markers of endothelial function (v.gr. nitric oxide, NO; prostacyclin, PGI2, etc.) |
| Quality of life questionnaire | 8 weeks | Improvement in quality of life questionnaire CLDQ (chronic liver disease questionnaire) |
| Changes in the heterogeneity of gut Microbiota | 8 weeks | Changes in the heterogeneity of fecal microbiota in terms of bacterial diversity will be assessed |
Outcome results
None listed