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

• ClinicalTrials.gov Identifier: NCT03689569
• Recruitment Status: Unknown
• First Posted: September 28, 2018
• Last Update Posted: October 9, 2018
• Sponsor: Springfield College
• Information provided by (Responsible Party): Samuel A. Headley, Springfield College

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Kidney Diseases	Dietary Supplement: Resistant starch; Behavioral: Exercise; Behavioral: Starch	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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
• Masking: Double (Participant, Investigator)
• Masking Description: 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.
• Primary Purpose: Prevention
• Official Title: Effects of Prebiotic Supplementation and Exercise on Inflammatory Markers, Vascular Function, Cognition, and Mental Well-being in Pre-Dialysis Kidney Patients
• Actual Study Start Date: September 18, 2018
• Estimated Primary Completion Date: May 31, 2021
• Estimated Study Completion Date: August 31, 2021

Arms and Interventions

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	Dietary Supplement: Resistant starch; Patients will receive 30 grams of resistant starch daily for 16 weeks or a placebo in a double blind fashion; Behavioral: Exercise; Patients randomized to the exercise group will train aerobically for 16 weeks at a moderate exercise intensity
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

Outcome Measures

Primary Outcome Measures :

1. Change in hs CRP [ Time Frame: baseline and after 16 weeks ]
   hsCRP
2. Change in TNF alpha [ Time Frame: Baseline and at week 16 ]
   TNFalpha
3. Change in IL6 [ Time Frame: Baseline and at week 16 ]
   IL6
4. Change in IL10 [ Time Frame: Baseline and at week 16 ]
   IL10
5. Change in MCP1 [ Time Frame: Baseline and at week 16 ]
   MCP1

Secondary Outcome Measures :

1. Change in vascular function [ Time Frame: Baseline, week 8 and week 16 ]
   Pulse wave velocity
2. Change in microbiome composition [ Time Frame: Baseline and after 16 weeks ]
   The composition of the microbiome will be assessed at baseline and after 16 weeks
3. Change in blood pressure [ Time Frame: Baseline & after 16 weeks ]
   central blood pressure

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Samuel A Headley, PhD; 413-748-3340; sheadley@springfieldcollege.edu

Contact: James Harnsberger, PhD; 413-748-4826; jharnsberger@springfieldcollege.edu

Locations

United States, Massachusetts

Springfield College; Recruiting

Springfield, Massachusetts, United States, 01109

Contact: Samuel A Headley, Ph.D 413-748-3340 ext 3340 sheadley@springfieldcollege.edu

Principal Investigator: Samuel A Headley, PhD

Principal Investigator: Michael J Germain, MD

Sponsors and Collaborators

Springfield College

Investigators

• Principal Investigator: Samuel A Headley, PhD; Springfield College

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Samuel A. Headley, Professor Exercise Science & Sport Studies, Springfield College
• ClinicalTrials.gov Identifier: NCT03689569
• Other Study ID Numbers: Prebiotic study
• First Posted: September 28, 2018
• Last Update Posted: October 9, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Samuel A. Headley, Springfield College:

microbiome; inflammation; resistant starch; exercise training

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Urologic Diseases; Renal Insufficiency