Effects of Prebiotic Supplementation and Exercise on Inflammatory Markers, Vascular Function and Cognition in CKD

NCT03689569 | Completed

• 1 other identifier: Prebiotic study
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The study is primarily designed to examine the effect of 16 weeks of prebiotic supplementation (resistant starch)and moderate intensity aerobic training on markers of inflammation in stage 3-4 patients with chronic kidney disease.

Conditions

Chronic Kidney Diseases

Keywords

microbiome; inflammation; resistant starch; exercise training

Outcome Measures

Primary Outcomes (5)

• Change in hs CRP

  hsCRP

  baseline and after 16 weeks

• Change in TNF alpha

  TNFalpha

  Baseline and at week 16

• Change in IL6

  IL6

  Baseline and at week 16

• Change in IL10

  IL10

  Baseline and at week 16

• Change in MCP1

  MCP1

  Baseline and at week 16

Secondary Outcomes (3)

• Change in vascular function

  Baseline, week 8 and week 16

• Change in microbiome composition

  Baseline and after 16 weeks

• Change in blood pressure

  Baseline & after 16 weeks

Study Arms (4)

Exercise

EXPERIMENTAL

Exercise only: Patients randomized to this group will receive a placebo (corn starch) and be given 16 weeks of personal training.

Behavioral: Exercise

Resistant Starch

EXPERIMENTAL

Resistant starch only: Patients randomized to this group will receive 30 g of resistant starch daily for 16 weeks. They will not be given an exercise training

Dietary Supplement: Resistant starch

Exercise & Resistant Starch

EXPERIMENTAL

Exercise \& resistant starch: Patients assigned to this group will do 16 weeks of personal training and they will be supplemented with 30 g of resistant starch daily for the 16 week period

Dietary Supplement: Resistant starch; Behavioral: Exercise

Starch

PLACEBO COMPARATOR

Corn starch only: Patients assigned to this group will not be given and exercise program and they will receive the placebo for 16 weeks

Behavioral: Starch

Interventions

Resistant starch DIETARY_SUPPLEMENT

Patients will receive 30 grams of resistant starch daily for 16 weeks or a placebo in a double blind fashion

Exercise & Resistant Starch; Resistant Starch

Exercise BEHAVIORAL

Patients randomized to the exercise group will train aerobically for 16 weeks at a moderate exercise intensity

Exercise; Exercise & Resistant Starch

Starch BEHAVIORAL

Patients will be given 30 grams of corn starch

Starch

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stage 3-4 of CKD (GFR 15-59 ml/min/1.73m2),
• ages of 30-75 years old,
• Must be capable of complying with and following the study protocol(diet and exercise)
• Must be capable of independently giving informed consent

You may not qualify if:

• kidney transplant
• currently in a structured exercise program
• on antibiotic therapy within the last month
• On a probiotic or prebiotic supplement within the last month
• a GI disorder that prohibits the use of resistant starch (ie. high-amylose corn starch, which resists digestion
• HIV positive
• gastric by-pass surgery
• clostridium difficile
• marijuana user
• lupus
• rheumatoid arthritis
• Hepatitis C
• Post-traumatic stress disorder
• deep vein thrombosis
• pancreatitis

Sponsors & Collaborators

• Springfield College: lead

Study Sites (1)

Springfield College

Springfield, Massachusetts, 01109, United States

Location

Related Publications (2)

• Cooper TE, Khalid R, Chan S, Craig JC, Hawley CM, Howell M, Johnson DW, Jaure A, Teixeira-Pinto A, Wong G. Synbiotics, prebiotics and probiotics for people with chronic kidney disease. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD013631. doi: 10.1002/14651858.CD013631.pub2.

  PMID: 37870148 DERIVED

• Headley SA, Chapman DJ, Germain MJ, Evans EE, Hutchinson J, Madsen KL, Ikizler TA, Miele EM, Kirton K, O'Neill E, Cornelius A, Martin B, Nindl B, Vaziri ND. The effects of 16-weeks of prebiotic supplementation and aerobic exercise training on inflammatory markers, oxidative stress, uremic toxins, and the microbiota in pre-dialysis kidney patients: a randomized controlled trial-protocol paper. BMC Nephrol. 2020 Nov 26;21(1):517. doi: 10.1186/s12882-020-02177-x.

  PMID: 33243160 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Inflammation

Interventions

Resistant Starch; Exercise; 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)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Samuel A Headley, PhD

  Springfield College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This will be a double blind study. Neither the participant nor the investigator will know what substance (resistant starch or corn starch) the participants will be consuming.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Exercise Science & Sport Studies

Model Details: An Intention-To-Treat design will be used in this study. Effects of treatment on all dependent variables will be assessed by a 2 (prebiotic supplement or control) by 2 (aerobic exercise or control) by 3 (time) mixed factor ANOVA

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 28, 2018
• Study Start: September 18, 2018
• Primary Completion: May 26, 2021
• Study Completion: May 26, 2021
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)