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

Primary Purpose

Chronic Kidney Disease, Hemodialysis, Non-dialysis Patients

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
'resistance starch for CKD
Placebo
Sponsored by
Universidade Federal Fluminense
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring chronic kidney disease, hemodialysis, conservative treatment, resistance starch

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Denise Mafra

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

resistance starch for CKD

cross-over period

Arm Description

- 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 18, 2016
Last Updated
October 18, 2020
Sponsor
Universidade Federal Fluminense
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1. Study Identification

Unique Protocol Identification Number
NCT02706808
Brief Title
Resistant Starch Supplementation Effects on the Intestinal Tract Profile and Cardiovascular Markers in Renal Patients
Acronym
Starch
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
October 2020 (Actual)
Study Completion Date
October 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal Fluminense

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Hemodialysis, Non-dialysis Patients
Keywords
chronic kidney disease, hemodialysis, conservative treatment, resistance starch

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
resistance starch for CKD
Arm Type
Experimental
Arm Description
- 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
Arm Title
cross-over period
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
'resistance starch for CKD
Intervention Description
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 Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Change in gut microbiota profile measured by denaturing gradient gel electrophoresis after supplementation of resistance starch treatment
Description
after 6 weeks with resistance starch the chronic kidney disease patients should have the gut microbiota modulated
Time Frame
Change from Baseline microbiota gut at 6 weeks
Title
Change in cytokines plasma levels measured by ELISA after supplementation of resistance starch
Description
after 6 weeks with resistance starch the chronic kidney disease patients should have the cytokines levels reduced
Time Frame
Change from Baseline inflammation at 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise Mafra, PhD
Organizational Affiliation
Federal university fluminense
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denise Mafra
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22260-050
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
34390604
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.
Results Reference
derived

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

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