Trial | NCT03689569  Report issue

Title

Effects of Prebiotic Supplementation and Exercise on Inflammatory Markers, Vascular Function and Cognition in CKD
Effects of Prebiotic Supplementation and Exercise on Inflammatory Markers, Vascular Function, Cognition, and Mental Well-being in Pre-Dialysis Kidney Patients

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    60
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.
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 Started
Sep 18
2018
Primary Completion
May 31
2021
Anticipated
Study Completion
Aug 31
2021
Anticipated
Last Update
Oct 09
2018

Dietary Supplement Resistant starch

Patients will receive 30 grams of resistant starch daily for 16 weeks or a placebo in a double blind fashion

Behavioral Exercise

Patients randomized to the exercise group will train aerobically for 16 weeks at a moderate exercise intensity

Behavioral Starch

Patients will be given 30 grams of corn starch

Exercise Experimental

Exercise only: Patients randomized to this group will receive a placebo (corn starch) and be given 16 weeks of personal training.

Resistant Starch Experimental

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

Exercise & Resistant Starch Experimental

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

Starch Placebo Comparator

Corn starch only: Patients assigned to this group will not be given and exercise program and they will receive the placebo for 16 weeks

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
No Results Posted