Chronic Kidney Diseases
Conditions
Keywords
microbiome, inflammation, resistant starch, exercise training
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.
Interventions
DIETARY_SUPPLEMENTResistant starch
Patients will receive 30 grams of resistant starch daily for 16 weeks or a placebo in a double blind fashion
BEHAVIORALExercise
Patients randomized to the exercise group will train aerobically for 16 weeks at a moderate exercise intensity
BEHAVIORALStarch
Patients will be given 30 grams of corn starch
Sponsors
Springfield College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
This will be a double blind study. Neither the participant nor the investigator will know what substance (resistant starch or corn starch) the participants will be consuming.
Intervention model description
An Intention-To-Treat design will be used in this study. Effects of treatment on all dependent variables will be assessed by a 2 (prebiotic supplement or control) by 2 (aerobic exercise or control) by 3 (time) mixed factor ANOVA
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in MCP1 | Baseline and at week 16 | MCP1 |
| Change in IL6 | Baseline and at week 16 | IL6 |
| Change in hs CRP | baseline and after 16 weeks | hsCRP |
| Change in IL10 | Baseline and at week 16 | IL10 |
| Change in TNF alpha | Baseline and at week 16 | TNFalpha |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in microbiome composition | Baseline and after 16 weeks | The composition of the microbiome will be assessed at baseline and after 16 weeks |
| Change in blood pressure | Baseline & after 16 weeks | central blood pressure |
| Change in vascular function | Baseline, week 8 and week 16 | Pulse wave velocity |
Countries
United States
Contacts
Primary ContactSamuel A Headley, PhD
Backup ContactJames Harnsberger, PhD
Outcome results
None listed