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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

No Placebo-Only Group

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.

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.

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.

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I am a child aged 5-17 with moderate kidney disease and low urine protein.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of subjects that consume at least 90% of the dietary resistant starch (RS).

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 2Eligibility criteria met