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

Not Applicable

Completed

• Conditions: Chronic Kidney Disease; Non-dialysis Patients; Hemodialysis
• Interventions: Dietary Supplement: 'resistance starch for CKD; Dietary Supplement: Placebo

• Registration Number: NCT02706808
• Lead Sponsor: Universidade Federal Fluminense

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-02-18
• Study First Submitted QC: 2016-03-10
• Study First Posted: 2016-03-11
• Status Verified: 2020-10
• Primary Completion: 2020-10
• Study Completion: 2020-10
• Last Update Submitted: 2020-10-18
• Last Update Posted: 2020-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
resistance starch for CKD	'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
cross-over period	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

Primary Outcome Measures

Name	Time	Method
Change in cytokines plasma levels measured by ELISA after supplementation of resistance starch	Change from Baseline inflammation at 6 weeks	after 6 weeks with resistance starch the chronic kidney disease patients should have the cytokines levels reduced
Change in gut microbiota profile measured by denaturing gradient gel electrophoresis after supplementation of resistance starch treatment	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

Trial Locations

Locations (1)

Denise Mafra; 🇧🇷 Rio de Janeiro, RJ, Brazil