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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03689569
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Samuel A. Headley, Springfield College

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.

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Starch

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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689569


Contacts
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Contact: Samuel A Headley, PhD 413-748-3340 sheadley@springfieldcollege.edu
Contact: James Harnsberger, PhD 413-748-4826 jharnsberger@springfieldcollege.edu

Locations
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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
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Principal Investigator: Samuel A Headley, PhD Springfield College
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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    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency