Chronic Kidney DiseasesNCT03356990
Effects of Resistant Starch Diet on the Gut Microbiome in Chronic Kidney Disease
A study testing Resistant Starch in people with Chronic Kidney Diseases, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 85 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Resistant Starch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2018to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 27Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
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.
Read the 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.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Resistant Starch
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistant StarchDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Resistant Starch | Experimental | 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). Receives: Dietary Supplement: Resistant Starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start12 Feb 2018
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- John M Arthur, MD, Ph.D., Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356990
- Sponsor's protocol ID
- 206708
- Other IDs
- 1P20GM121293
- Status last verified
- Mar 2025
- First submitted
- 14 Nov 2017
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistant Starch Diet on the Gut Microbiome in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03356990
- Acronym / sponsor ID
- 206708
- Conditions
- Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 29 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resistant Starch | Experimental | Dietary Supplement: Resistant StarchIntervention: 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). |
Who may qualify
- Ages
- 5 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Adult
- Children
Key exclusion criteria (27 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistant StarchDietary 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. | Dietary supplement | Resistant Starch |
Primary outcome
Percentage of subjects that consume at least 90% of the dietary resistant starch (RS).
Time frame: 2 weeks
Packaging will be returned by the subject at the end of the time period in order to determine compliance.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John M Arthur, MD, Ph.D. principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistant Starch in people with Chronic Kidney Diseases, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects that consume at least 90% of the dietary resistant starch (RS). (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.