Clinical trial NCT02706808: Resistant Starch Supplementation Effects on the Intestinal Tract Profile and Cardiovascular Markers in Renal Patients
Official title: Effects of Supplementation With Resistant Starch in the Profile of the Intestinal Tract and Cardiovascular Markers in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Hemodialysis
Non-dialysis Patients
Keywords: chronic kidney disease
hemodialysis
conservative treatment
resistance starch
Lead sponsor: Universidade Federal Fluminense
Sponsor class: OTHER
First posted: 2016-03-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Hemodialysis patients with arteriovenous fistula as vascular access in the upper limb and on maintenance dialysis for at least 6 months;
* Patients under conservative treatment in stages 3a and 3b (30 to 60 mL / min) of chronic kidney disease and receiving nutritional treatment for at least 6 months (adequate supply of energy 30-35kcal/kg/day and hypoproteic 0.6 g/kg/day.

Exclusion Criteria:

* Patients with autoimmune and infectious diseases, diabetes, cancer and AIDS;
* Patients with catheter for hemodialysis access;
* Patients using catabolizing drugs, supplements as antioxidant vitamin, probiotics, prebiotics, synbiotics and antibiotics.
* Patients who exercise are also deleted.

Primary outcomes:
measure: Change in gut microbiota profile measured by denaturing gradient gel electrophoresis after supplementation of resistance starch treatment
timeFrame: Change from Baseline microbiota gut at 6 weeks
measure: Change in cytokines plasma levels measured by ELISA after supplementation of resistance starch
timeFrame: Change from Baseline inflammation at 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Denise Mafra
state: RJ
Study officials:
affiliation: Federal university fluminense
name: Denise Mafra, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kemp JA, Regis de Paiva B, Fragoso Dos Santos H, Emiliano de Jesus H, Craven H, Z Ijaz U, Alvarenga Borges N, G Shiels P, Mafra D. The Impact of Enriched Resistant Starch Type-2 Cookies on the Gut Microbiome in Hemodialysis Patients: A Randomized Controlled Trial. Mol Nutr Food Res. 2021 Oct;65(19):e2100374. doi: 10.1002/mnfr.202100374. Epub 2021 Aug 22.