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Effects of Resistant Starch Diet on the Gut Microbiome in Chronic Kidney Disease

Primary Purpose

Chronic Kidney Diseases

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistant Starch
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Kidney Diseases

Eligibility Criteria

5 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult

    • Between the ages of 18 and 85 years old
    • Glomerular filtration rate estimated by creatinine clearance (eGFR Cr):between 59 and 30 ml/min for stage 3 CKD patients
    • Urine protein < 1 gram per day by 24-hour protein collection or urine protein-to-creatinine ratio <1 gram/gram or urine microalbumin to creatinine concentration less than 1000 mg/g.
  • Children

    • Between the ages of 5 and 17 years
    • eGFR Cr between 30 and 59 (stage 3 CKD) using the revised Schwartz equation.
    • Urine protein < 1 gram per day by 24-hour protein collection or urine protein-to-creatinine ratio <1 gram/gram.

Exclusion Criteria:

Adult

  • Age older than 85 years
  • eGFR Cr > 59 ml/min or < 30 ml/min
  • History of renal transplant
  • Subject with diabetes (as defined by patient report, taking medications for the treatment of diabetes or as reported in the medical record)
  • Use of antibiotics within 1 month
  • Use of laxatives within 1 month
  • Inflammatory bowel disease
  • Irritable bowel syndrome
  • Colorectal cancer
  • Surgically removed bowel or presence of an ostomy
  • Pregnancy
  • Inability to obtain written informed consent
  • Constipation
  • Diarrhea

Children

  • Age younger than 5 years
  • eGFR > 59 ml/min and < 30 ml/min
  • History of renal transplant
  • Subject with diabetes (as defined by patient report, taking medications for the treatment of diabetes or as reported in the medical record)
  • Use of antibiotics within 1 month
  • Use of laxatives within 1 month
  • Inflammatory bowel disease
  • Surgically removed bowel or presence of an ostomy
  • Pregnancy
  • Constipation
  • Diarrhea

Sites / Locations

  • University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Resistant Starch

Arm Description

Intervention: Dietary supplement will be taken every day for total of 2 weeks. Each participant will be take half the dose of Hi-Maze 260 or "High RS Gummy Chews" in the morning and the other half dose in the evening Adult participants are asked to introduce in their diet 30 grams of high RS supplement each day of the diet period (2 weeks). Children of age included between 5 and 9 years are asked to introduce in their diet 10 grams of high RS supplement each day of the diet period (2 weeks). Children of age included between 10 and 17 years are asked to introduce in their diet 15 grams of high RS supplement each day of the diet period (2 weeks).

Outcomes

Primary Outcome Measures

Percentage of subjects that consume at least 90% of the dietary resistant starch (RS).
Packaging will be returned by the subject at the end of the time period in order to determine compliance.

Secondary Outcome Measures

Full Information

First Posted
November 14, 2017
Last Updated
July 13, 2023
Sponsor
University of Arkansas
Collaborators
National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT03356990
Brief Title
Effects of Resistant Starch Diet on the Gut Microbiome in Chronic Kidney Disease
Official Title
Effects of Resistant Starch Diet on the Gut Microbiome in Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
Collaborators
National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators want to learn more about how to help people who have chronic kidney disease (CKD). This study will increase the investigators understanding of how diet affects factors that can slow the progression of kidney disease. The investigators are asking 30 adults and 30 children with stage 3 CKD to be part of this study. Participants will supplement their diet with resistant starch for two weeks. The investigators anticipate that the resistant starch will change the bacteria in the intestines to a more beneficial type of bacteria. The investigators will measure a product of these beneficial bacteria called butyrate. The investigators will also determine changes in the gut bacteria and products of the bacteria in the blood.
Detailed Description
Chronic kidney disease (CKD), a progressive decline in kidney function, is a growing health problem: 13% of adults in the US have CKD. Among patients with CKD, the risk of progression to irreversible loss of kidney function (end-stage renal disease, ESRD) is about 1% per year. In addition, adjusted mortality is approximately four times greater among those with CKD compared to those without. For ESRD, apart from dialysis and kidney transplant, no treatment exists. CKD increases urea levels in bodily fluids leading to a dominance of urease-containing bacteria in the gut. Such dysbiosis results in decreased production of the short chain fatty acid, butyrate and decreased health of the colonic epithelial barrier. Consequently, bacterial toxins translocate into the bloodstream, promoting inflammation. Moreover, production of uremic toxins such as indoxyl and p-cresyl sulfates are also increased, resulting in further kidney injury. CKD patients are prescribed a diet low in protein, fiber and symbiotic organisms, which reduces complications like hyperkalemia, but also contributes to the dysbiosis. Re-formulating the CKD diet may improve the clinical management of CKD. The investigators's overall hypothesis is that changes in the microbial diversity, xeno-proteins and xeno-metabolites correlate with CKD progression, and microbiome-directed therapies can be used to slow the disease. In this study, the investigators will determine the tolerability of supplemental resistant starch (RS). Secondary aims are to determine if a diet high in resistant starch changes fecal butyrate concentrations, the make-up of the gut microbiome and the concentrations in the blood of uremic toxins produced by the gut microbiome. This study will help in the design of a future study with the aim of understanding if a high resistant starch diet can slow the progression of chronic kidney disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Resistant Starch
Arm Type
Experimental
Arm Description
Intervention: Dietary supplement will be taken every day for total of 2 weeks. Each participant will be take half the dose of Hi-Maze 260 or "High RS Gummy Chews" in the morning and the other half dose in the evening Adult participants are asked to introduce in their diet 30 grams of high RS supplement each day of the diet period (2 weeks). Children of age included between 5 and 9 years are asked to introduce in their diet 10 grams of high RS supplement each day of the diet period (2 weeks). Children of age included between 10 and 17 years are asked to introduce in their diet 15 grams of high RS supplement each day of the diet period (2 weeks).
Intervention Type
Dietary Supplement
Intervention Name(s)
Resistant Starch
Intervention Description
Dietary supplement will be taken every day for total of 2 weeks. Each participant will be take half the dose (one bag) of Hi-Maze 260 or "High RS Gummy Chews" in the morning and the other half dose (one bag) in the evening.
Primary Outcome Measure Information:
Title
Percentage of subjects that consume at least 90% of the dietary resistant starch (RS).
Description
Packaging will be returned by the subject at the end of the time period in order to determine compliance.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult Between the ages of 18 and 85 years old Glomerular filtration rate estimated by creatinine clearance (eGFR Cr):between 59 and 30 ml/min for stage 3 CKD patients Urine protein < 1 gram per day by 24-hour protein collection or urine protein-to-creatinine ratio <1 gram/gram or urine microalbumin to creatinine concentration less than 1000 mg/g. Children Between the ages of 5 and 17 years eGFR Cr between 30 and 59 (stage 3 CKD) using the revised Schwartz equation. Urine protein < 1 gram per day by 24-hour protein collection or urine protein-to-creatinine ratio <1 gram/gram. Exclusion Criteria: Adult Age older than 85 years eGFR Cr > 59 ml/min or < 30 ml/min History of renal transplant Subject with diabetes (as defined by patient report, taking medications for the treatment of diabetes or as reported in the medical record) Use of antibiotics within 1 month Use of laxatives within 1 month Inflammatory bowel disease Irritable bowel syndrome Colorectal cancer Surgically removed bowel or presence of an ostomy Pregnancy Inability to obtain written informed consent Constipation Diarrhea Children Age younger than 5 years eGFR > 59 ml/min and < 30 ml/min History of renal transplant Subject with diabetes (as defined by patient report, taking medications for the treatment of diabetes or as reported in the medical record) Use of antibiotics within 1 month Use of laxatives within 1 month Inflammatory bowel disease Surgically removed bowel or presence of an ostomy Pregnancy Constipation Diarrhea
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John M Arthur, MD, Ph.D.
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Resistant Starch Diet on the Gut Microbiome in Chronic Kidney Disease

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