Clinical trial NCT03689569: Effects of Prebiotic Supplementation and Exercise on Inflammatory Markers, Vascular Function and Cognition in CKD
Official title: Effects of Prebiotic Supplementation and Exercise on Inflammatory Markers, Vascular Function, Cognition, and Mental Well-being in Pre-Dialysis Kidney Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: microbiome
inflammation
resistant starch
exercise training
Lead sponsor: Springfield College
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in hs CRP
timeFrame: baseline and after 16 weeks
measure: Change in TNF alpha
timeFrame: Baseline and at week 16
measure: Change in IL6
timeFrame: Baseline and at week 16
measure: Change in IL10
timeFrame: Baseline and at week 16
measure: Change in MCP1
timeFrame: Baseline and at week 16
Secondary outcomes:
measure: Change in vascular function
timeFrame: Baseline, week 8 and week 16
measure: Change in microbiome composition
timeFrame: Baseline and after 16 weeks
measure: Change in blood pressure
timeFrame: Baseline & after 16 weeks
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Springfield College
state: Massachusetts
Study officials:
affiliation: Springfield College
name: Samuel A Headley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Headley SA, Chapman DJ, Germain MJ, Evans EE, Hutchinson J, Madsen KL, Ikizler TA, Miele EM, Kirton K, O'Neill E, Cornelius A, Martin B, Nindl B, Vaziri ND. The effects of 16-weeks of prebiotic supplementation and aerobic exercise training on inflammatory markers, oxidative stress, uremic toxins, and the microbiota in pre-dialysis kidney patients: a randomized controlled trial-protocol paper. BMC Nephrol. 2020 Nov 26;21(1):517. doi: 10.1186/s12882-020-02177-x.