Springfield College
Springfield, Massachusetts, 01109, United States
NCT Number: NCT03689569
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.
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Notify Me30 year–75 year
All sexes
Interventional
Not applicable
Springfield, Massachusetts, 01109, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: baseline and after 16 weeks
hsCRP
Time frame: Baseline and at week 16
TNFalpha
Time frame: Baseline and at week 16
IL6
Time frame: Baseline and at week 16
IL10
Time frame: Baseline and at week 16
MCP1
Time frame: Baseline, week 8 and week 16
Pulse wave velocity
Time frame: Baseline and after 16 weeks
The composition of the microbiome will be assessed at baseline and after 16 weeks
Time frame: Baseline & after 16 weeks
central blood pressure
Springfield College
Other
Effects of Prebiotic Supplementation and Exercise on Inflammatory Markers, Vascular Function, Cognition, and Mental Well-being in Pre-Dialysis Kidney Patients
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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