Fructans, Lactitol and Lactose in Minimal Hepatic Encephalopathy
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Hepatic Encephalopathy; Brain Diseases
Study type: Interventional

Summary: 
      As an alternative for the treatment of Minimal Hepatic Encephalopathy (MHE) Agave fructans
      have shown prebiotic effects, and have shown to improve function of the digestive system,
      control and induce glycemic effect satiety. Therefore the impact of the fermentation of such
      prebiotic in the gut may contribute to improving health and quality of life of patients with
      MHE.
    

Detailed description: 
      Hepatic encephalopathy (HE) is a potentially reversible neuropsychiatric syndrome
      characterized by changes in cognitive function, behavior and personality of patients with
      chronic liver disease or cirrhosis. Increased concentration of ammonia is the main
      precipitant of encephalopathy and brain astrocytes are the main affected cells in the
      neuropathology of this disease. The toxicity of ammonia together with the neutrophil
      dysfunction and oxidative stress and inflammation secondary to infection, result in a
      progressive decline in quality of life and an increased risk of accidents for patients with
      this disease.

      About 28% of patients with liver cirrhosis develop encephalopathy during the course of the
      disease and within this percentage, 84% will develop MHE. Currently, chronic liver diseases
      are the third leading cause of death in Mexico. The high prevalence suggests that HE could
      become a public health problem, with the 2020 projected figures of 1.5 million people with
      cirrhosis, which represents approximately 400 000 to 500 000 people with probable
      encephalopathy.

      The usual treatment of MHE is the use of antibiotics or pro and prebiotics, these enhances
      the performance and quality of life of patients who have the disease. The general consensus
      has been using lactulose or lactitol as the first treatment options for MHE consistent with
      data from previous studies. However, the rate of adherence to treatment with lactulose and
      lactitol is low, especially in patients with MHE with no symptoms and lack of specific
      information about their problems, to adhere to medications that can cause diarrhea and
      flatulence.

      In the last eight years functional ingredients have been studied as alternatives to the
      treatment of patients with MHE. In 2004, Liu et al showed that 25% chicory inulin (prebiotic)
      and this combined with probiotics improve the psychometric function of MHE patients. In
      similar studies conducted in 2007 and 2009 in which they used a formulation with a symbiotic
      fructo-oligosaccharides based chicory inulin and B. longum, showed improvement in
      psychometric tests applied to patients. In 2008, Bajaj et al showed that patients who
      consumed a yogurt with probiotics, showed significant changes in the degree of MHE.

      As an alternative for treating the MHE we found Agave tequilana Weber fructans, which present
      prebiotic effect, besides having shown to improve the function of the digestive system,
      control and induce glycemic effect satiety. Therefore the impact of the fermentation of such
      prebiotic in the gut may contribute to improving the health and quality of life of patients
      with MHE.
    

Intervention name(s): Red cereal bar; Green cereal bar; White cereal bar
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Consumption of the cereal bar with agave fructans or lactitol or lactose added each bar with 10 grams of dietary fiber and 1.2 grams of protein by weight and 20 to 30 grams of fiber.; Consumption of the cereal bar with agave fructans or lactitol or lactose added each bar with 10 grams of dietary fiber and 1.2 grams of protein by weight and 20 to 30 grams of fiber.; Consumption of the cereal bar with agave fructans or lactitol or lactose added each bar with 10 grams of dietary fiber and 1.2 grams of protein by weight and 20 to 30 grams of fiber.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Minimal hepatic encephalopathy; Hepatic encephalopathy