NCT02706808

Resistant Starch Supplementation Effects on the Intestinal Tract Profile and Cardiovascular Markers in Renal Patients

Effects of Supplementation With Resistant Starch in the Profile of the Intestinal Tract and Cardiovascular Markers in Patients With Chronic Kidney Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Universidade Federal Fluminense · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Kidney Disease
• Hemodialysis
• Non-dialysis Patients

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	'resistance starch for CKD	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
DIETARY_SUPPLEMENT	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

Timeline

• Start date: 2015-12-01
• Primary completion: 2020-10-01
• Completion: 2020-10-01
• First posted: 2016-03-11
• Last updated: 2020-10-20

Locations

1 site across 1 country: Brazil