Denise Mafra
Rio de Janeiro, 22260-050, Brazil
NCT Number: NCT02706808
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.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Rio de Janeiro, 22260-050, Brazil
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Change from Baseline microbiota gut at 6 weeks
after 6 weeks with resistance starch the chronic kidney disease patients should have the gut microbiota modulated
Time frame: Change from Baseline inflammation at 6 weeks
after 6 weeks with resistance starch the chronic kidney disease patients should have the cytokines levels reduced
Universidade Federal Fluminense
Other
Effects of Supplementation With Resistant Starch in the Profile of the Intestinal Tract and Cardiovascular Markers in Patients With Chronic Kidney Disease
Acronym: Starch
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