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



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:30 - 75
Updated:10/10/2018
Start Date:September 18, 2018
End Date:August 31, 2021
Contact:Samuel A Headley, PhD
Email:sheadley@springfieldcollege.edu
Phone:413-748-3340

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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.

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.

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
We found this trial at
1
site
263 Alden Street
Springfield, Massachusetts 01109
Principal Investigator: Samuel A Headley, PhD
Phone: 413-748-3340
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Springfield, MA
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