Resistant Starch Diet for Chronic Kidney Disease

Overseen By Tawana L Gibbs, MA,MET

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas

Must not be taking: Antibiotics, Laxatives

Disqualifiers: Diabetes, Inflammatory bowel, Colorectal cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a diet with resistant starch affects people with chronic kidney disease (CKD). Researchers hope this special starch will improve gut bacteria, potentially slowing kidney disease progression. Participants will add this starch to their diet for two weeks, while researchers observe changes in gut bacteria and related blood products. The trial seeks adults and children with stage 3 CKD who haven't used antibiotics or laxatives in the past month and don't have diabetes or bowel issues. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new dietary recommendations for CKD patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking antibiotics or laxatives, you must not have used them within the last month to participate.

What prior data suggests that this diet is safe for people with chronic kidney disease?

Research shows that resistant starch is generally easy for most people to handle. Studies have found that it can help individuals with chronic kidney disease (CKD) by improving the balance of gut bacteria. In some cases, it also reduces harmful substances in the body.

Reports of serious side effects are rare. Most people digest resistant starch without issues. It might cause mild gas or bloating, but these effects usually resolve quickly.

Overall, evidence suggests that resistant starch is safe for people with CKD, but individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for chronic kidney disease, which often focus on managing symptoms through medication and lifestyle changes, resistant starch offers a unique dietary approach. Resistant starch is a type of carbohydrate that resists digestion in the small intestine, reaching the colon where it acts as a prebiotic, promoting healthy gut bacteria. This could potentially improve kidney function by reducing toxin buildup in the body. Researchers are excited because this approach could complement existing treatments, offering a simple, natural addition to the diet that might enhance overall kidney health.

What evidence suggests that resistant starch might be an effective treatment for chronic kidney disease?

Research has shown that resistant starch, which participants in this trial will receive, can benefit people with chronic kidney disease (CKD). Studies have found that it lowers certain waste products in the blood, such as indolephenol sulfate and uric acid, which are often elevated in individuals with kidney issues. It also appears to reduce blood phosphorus and IL-6, a marker of inflammation. Although it doesn't significantly alter inflammation levels, it improves kidney function by reducing harmful toxins. Resistant starch might also promote beneficial changes in gut bacteria, potentially slowing the progression of kidney disease. ^{3 4 6 7 8}

Who Is on the Research Team?

John M Arthur, MD, Ph.D.

Principal Investigator

University of Arkansas

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am 18-85 years old with moderate kidney function and low urine protein.

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

Exclusion Criteria

I am under 5, have specific kidney function, or have certain health conditions or treatments.

I am not over 85, have stable kidney function, and none of the listed health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants supplement their diet with resistant starch for two weeks

2 weeks

1 visit (in-person) at the start, 1 visit (in-person) at the end

Follow-up

Participants are monitored for changes in gut microbiome and blood uremic toxins

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Resistant Starch

Trial Overview 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.

How Is the Trial Designed?

Group I: Resistant Starch Experimental Treatment 1 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).

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9314005/

Effects of Resistant Starch on Patients with Chronic Kidney ... RS intake significantly reduced serum indolephenol sulfate (IS), blood phosphorus, IL-6, and uric acid levels in dialysis patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8785497/

A randomized double-blind cross-over trial to study the ... This study aims to investigate the effects of resistant potato starch (RPS) as a prebiotic in individuals with CKD before the onset of dialysis.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04961164

Resistant Starch Prebiotic Effects in Chronic Kidney Disease The goal of this project is to investigate whether the consumption of resistant potato starch (RPS) as an adjunctive therapy to current standard of CKD care ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/0886022X.2024.2416609

Effects of resistant starch supplementation on renal ... RS supplementation can reduce uremic toxin levels and improve renal function but does not reduce the inflammatory response in patients with CKD.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/fft2.474

Resistant starch, chronic kidney disease, and the gut ... Results demonstrate decreased tubulointerstitial injury in the CKD/RS group when compared to the CKD group, but no difference in BUN ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11504232/

Effects of resistant starch supplementation on renal function ... RS supplementation can reduce uremic toxin levels and improve renal function but does not reduce the inflammatory response in patients with CKD.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9280786/

The Effects of Resistant Starch Consumption in Adult Patients ... Resistant starch supplementation has shown promising results in altering the microbiota of animal models of chronic kidney disease (CKD).

8. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06009-1

A randomized double-blind cross-over trial to study the effects ... This study aims to investigate the effects of resistant potato starch (RPS) as a prebiotic in individuals with CKD before the onset of dialysis.