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

NCT02706808 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-10-20

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Universidade Federal Fluminense

    lead OTHER

Principal Investigators

  • Denise Mafra, PhD · Federal university fluminense

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2020-10-31
Completion
2020-10-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02706808 on ClinicalTrials.gov