Effects of Prebiotic Supplementation and Exercise on Inflammatory Markers, Vascular Function and Cognition in CKD
- Conditions
- Chronic Kidney Diseases
- Interventions
- Behavioral: ExerciseDietary Supplement: Resistant starchBehavioral: Starch
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
- Arm && Interventions
Group Intervention Description Exercise Exercise Exercise only: Patients randomized to this group will receive a placebo (corn starch) and be given 16 weeks of personal training. Exercise & Resistant Starch 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 Exercise & Resistant Starch Exercise 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 Resistant Starch 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 Starch 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
- 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