Effect of a Multifactorial Intervention (Non-alcoholic Beer, Diet and Exercise) on Endothelial Function, Nutritional Status and Quality of Life in Patients With Cirrhosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endothelial Dysfunction
- Sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Enrollment
- 42
- Primary Endpoint
- Quality of life questionnaire
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Quality of life questionnaire
Time Frame: 8 weeks
Improvement in quality of life questionnaire CLDQ (chronic liver disease questionnaire)
Nutritional status
Time Frame: 8 weeks
improvement in impedance-derived phase angle (PhA)
Endothelial dysfunction
Time Frame: 8 weeks
improvement in serum markers of endothelial function (v.gr. nitric oxide, NO; prostacyclin, PGI2, etc.)
Changes in the heterogeneity of gut Microbiota
Time Frame: 8 weeks
Changes in the heterogeneity of fecal microbiota in terms of bacterial diversity will be assessed
Endothelial function
Time Frame: 8 weeks
improvement in flow-mediated dilation (brachial artery)