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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
60
Patients will receive 30 grams of resistant starch daily for 16 weeks or a placebo in a double blind fashion
Patients randomized to the exercise group will train aerobically for 16 weeks at a moderate exercise intensity
Patients will be given 30 grams of corn starch
Springfield College
Springfield, Massachusetts, United States
RECRUITINGChange in hs CRP
hsCRP
Time frame: baseline and after 16 weeks
Change in TNF alpha
TNFalpha
Time frame: Baseline and at week 16
Change in IL6
IL6
Time frame: Baseline and at week 16
Change in IL10
IL10
Time frame: Baseline and at week 16
Change in MCP1
MCP1
Time frame: Baseline and at week 16
Change in vascular function
Pulse wave velocity
Time frame: Baseline, week 8 and week 16
Change in microbiome composition
The composition of the microbiome will be assessed at baseline and after 16 weeks
Time frame: Baseline and after 16 weeks
Change in blood pressure
central blood pressure
Time frame: Baseline & after 16 weeks
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