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

Effects of Prebiotic Supplementation and Exercise on Inflammatory Markers, Vascular Function, Cognition, and Mental Well-being in Pre-Dialysis Kidney Patients

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Behavioral: Exercise; Dietary supplement: Resistant starch; Behavioral: Starch

Detailed Description

The primary aim of the proposed study is to determine whether the consumption of a prebiotic supplement (resistant starch) coupled with moderate intensity endurance training over 16 weeks leads to reductions in key inflammatory markers in stage 3-4 predialysis CKD patients and whether this reduction is associated with favorable changes in vascular function and indicators of stress and emotional reactivity.

The investigators hypothesize that supplementation with the prebiotic (resistant starch) will lead to normalization of the microbiome of our sample of patients with chronic kidney disease (CKD) and reduce key markers of inflammation. Reductions in these biomarkers will be associated with favorable changes in cardiovascular variables along with indices of stress and emotional reactivity. Moderate intensity aerobic training will have an additive anti-inflammatory effect along with the consumption of the resistant starch.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samuel A Headley, PhD; Phone Number: 413-748-3340; Email: sheadley@springfieldcollege.edu
• Study Contact Backup: Name: James Harnsberger, PhD; Phone Number: 413-748-4826; Email: jharnsberger@springfieldcollege.edu

Study Locations

• United States
  • Massachusetts
    • Springfield, Massachusetts, United States, 01109
      • Recruiting
      • Springfield College
      • Contact: Samuel A Headley, Ph.D; Phone Number: 3340 413-748-3340; Email: sheadley@springfieldcollege.edu
      • Principal Investigator: Samuel A Headley, PhD
      • Principal Investigator: Michael J Germain, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise; Exercise only: Patients randomized to this group will receive a placebo (corn starch) and be given 16 weeks of personal training.	Behavioral: Exercise; Patients randomized to the exercise group will train aerobically for 16 weeks at a moderate exercise intensity
Experimental: Resistant Starch; 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; Patients will receive 30 grams of resistant starch daily for 16 weeks or a placebo in a double blind fashion
Experimental: Exercise & Resistant Starch; 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	Behavioral: Exercise; Patients randomized to the exercise group will train aerobically for 16 weeks at a moderate exercise intensity; Dietary supplement: Resistant starch; Patients will receive 30 grams of resistant starch daily for 16 weeks or a placebo in a double blind fashion
Placebo Comparator: Starch; 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; Patients will be given 30 grams of corn starch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in vascular function	Pulse wave velocity	Baseline, week 8 and week 16
Change in microbiome composition	The composition of the microbiome will be assessed at baseline and after 16 weeks	Baseline and after 16 weeks
Change in blood pressure	central blood pressure	Baseline & after 16 weeks

Collaborators and Investigators

• Sponsor: Springfield College
• Investigators: Principal Investigator: Samuel A Headley, PhD, Springfield College

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2018
• Primary Completion (Anticipated): May 31, 2021
• Study Completion (Anticipated): August 31, 2021

Study Registration Dates

• First Submitted: September 19, 2018
• First Submitted That Met QC Criteria: September 27, 2018
• First Posted (Actual): September 28, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 4, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: inflammation; exercise training; microbiome; resistant starch
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: Prebiotic study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No