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Dietary Supplement

Resistant Starch Diet for Chronic Kidney Disease

N/A
Waitlist Available
Led By John M Arthur, MD, Ph.D.
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults between the ages of 18 and 85 years old with glomerular filtration rate estimated by creatinine clearance (eGFR Cr) between 59 and 30 ml/min for stage 3 CKD patients and 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 with eGFR Cr between 30 and 59 (stage 3 CKD) using the revised Schwartz equation and urine protein < 1 gram per day by 24-hour protein collection or urine protein-to-creatinine ratio <1 gram/gram.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights

Study Summary

This trial will help researchers understand how diet can affect factors that slow the progression of kidney disease.

Who is the study for?
This trial is for adults aged 18-85 and children 5-17 with stage 3 chronic kidney disease (CKD), having specific levels of kidney function and protein in urine. Excluded are those under age 5 or over 85, with certain medical conditions like diabetes, recent antibiotic use, bowel diseases, past kidney transplants, pregnancy, or extreme bowel habits.Check my eligibility
What is being tested?
The study tests if a diet supplemented with resistant starch can benefit the gut microbiome in CKD patients. It aims to see if this change improves bacterial byproducts like butyrate that might slow down CKD progression. The participants will add resistant starch to their diets for two weeks.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include digestive changes such as bloating or gas due to increased fiber from the resistant starch.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18-85 years old with moderate kidney function and low urine protein.
Select...
I am a child aged 5-17 with moderate kidney disease and low urine protein.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of subjects that consume at least 90% of the dietary resistant starch (RS).

Trial Design

1Treatment groups
Experimental Treatment
Group I: Resistant StarchExperimental Treatment1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Resistant Starch
2006
N/A
~140

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor
485 Previous Clinical Trials
149,813 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,679 Previous Clinical Trials
6,910,622 Total Patients Enrolled
National Institute of General Medical Sciences (NIGMS)NIH
267 Previous Clinical Trials
248,544 Total Patients Enrolled

Media Library

Chronic Kidney Disease Research Study Groups: Resistant Starch
Chronic Kidney Disease Clinical Trial 2023: Resistant Starch Highlights & Side Effects. Trial Name: NCT03356990 — N/A
Resistant Starch (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03356990 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals still being enrolled in this experiment?

"Clinicaltrials.gov reflects that this clinical trial is no longer seeking new patients, having been initially posted on February 12th 2018 and most recently updated on August 5th 2022. However, there are a plethora of alternative studies currently looking for participants to join their trials."

Answered by AI

Does this experiment permit participants aged thirty or above?

"Eligibility for this study requires participants to be over 5 years old and below 85."

Answered by AI

What criteria must be met to participate in this research endeavor?

"This on-going clinical trial is looking for 60 CKD patients ranging from 5 to 85 years old. To qualify, individuals must have a urine protein level < 1g per day via 24 hour collection or a UPC ratio <1 and/or UMA concentration less than 1000 mg/g; children must meet the same criteria except they are not required to provide 24 hr collections. Additionally, all candidates should possess an eGFR Cr between 30 and 59 (Stage 3), according to the revised Schwartz equation."

Answered by AI
~4 spots leftby Sep 2024