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

Not Applicable

• Conditions: Chronic Kidney Diseases

• Registration Number: NCT03689569
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-09-18
• Study First Submitted: 2018-09-19
• Study First Submitted QC: 2018-09-27
• Study First Posted: 2018-09-28
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-04
• Last Update Posted: 2018-10-09
• Primary Completion: 2021-05-31
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in hs CRP	baseline and after 16 weeks	hsCRP
Change in TNF alpha	Baseline and at week 16	TNFalpha
Change in IL6	Baseline and at week 16	IL6
Change in IL10	Baseline and at week 16	IL10
Change in MCP1	Baseline and at week 16	MCP1

Secondary Outcome Measures

Name	Time	Method
Change in vascular function	Baseline, week 8 and week 16	Pulse wave velocity
Change in blood pressure	Baseline & after 16 weeks	central blood pressure
Change in microbiome composition	Baseline and after 16 weeks	The composition of the microbiome will be assessed at baseline and after 16 weeks

Trial Locations

Locations (1)

Springfield College; 🇺🇸 Springfield, Massachusetts, United States