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

NCT03356990 | Completed

• 2 other identifiers: 2067081P20GM121293
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks

Study Arms (1)

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).

Dietary Supplement: Resistant Starch

Interventions

Resistant Starch DIETARY_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.

Resistant Starch

Eligibility Criteria

• Age: 5 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead
• National Institutes of Health (NIH): collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Resistant Starch

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• John M Arthur, MD, Ph.D.

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 29, 2017
• Study Start: February 12, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)