Resistant Starch Supplementation Effects on the Intestinal Tract Profile and Cardiovascular Markers in Renal Patients
Condition: Chronic Kidney Disease; Hemodialysis; Non-dialysis Patients
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      The objective of this study is to assess whether supplementation with resistant starch from
      the rice-flour coffee developed by EMBRAPA, as well as from an already industrialized product
      (Hi-Maize of Ingredion®) could modulate the intestinal microbiota of patients with CKD ( both
      patients under conservative treatment, such as dialysis treatment), as well as exerting a
      beneficial effect with respect to reducing levels of inflammatory markers of oxidative
      stress, uremic toxins and in addition, markers of cardiovascular disease.
    

Detailed description: 
      Patients with chronic kidney disease (CKD), especially those who are on dialysis have a high
      prevalence of cardiovascular mortality and, among the risk factors include inflammation and
      oxidative stress. Recently this scenario, beyond those alterations found in these patients,
      it has been suggested that the balance of the intestinal flora in these patients might be a
      new factor of cardiovascular risk. Some treatment strategies have been studied in order to
      modulate the gut microbiota as the use of pre, pro or synbiotics. Although few studies,
      supplementation with prebiotics has been recommended. However, the use of resistant starch as
      a source of prebiotic for modulation of the intestinal flora in these patients has not yet
      been evaluated, but the study of Prof. Vaziri the University of California Irvine, USA, with
      nephrectomized rats showed that the resistant starch was able to attenuating the progression
      of failure of renal function, inflammation and oxidative stress and minimize the
      abnormalities of intestinal epithelial barrier. The objective of this study is to assess
      whether supplementation with resistant starch from the rice-flour coffee developed by
      EMBRAPA, as well as from an already industrialized product (Hi-Maize of Ingredion®) could
      modulate the intestinal microbiota of patients with CKD ( both patients under conservative
      treatment, such as dialysis treatment), as well as exerting a beneficial effect with respect
      to reducing levels of inflammatory markers of oxidative stress, uremic toxins and in
      addition, markers of cardiovascular disease.
    

Intervention name(s): 'resistance starch for CKD; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Intervention period (6 weeks): Group A - patients will receive 6 cookies/day containing resistant starch (18g/day); Group B - patients will receive 6 cookies/day containing placebo; Intervention period (6 weeks): Group B - patients will receive 6 cookies/day containing resistant starch (18g/day); Group A - patients will receive 6 cookies/day containing placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic kidney disease; hemodialysis; conservative treatment; resistance starch