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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-18

Study Completion Date

2021-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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Exercise

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

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

Resistant starch

Intervention Type DIETARY_SUPPLEMENT

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

Exercise & 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

Group Type EXPERIMENTAL

Resistant starch

Intervention Type DIETARY_SUPPLEMENT

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

Exercise

Intervention Type BEHAVIORAL

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

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

Group Type PLACEBO_COMPARATOR

Starch

Intervention Type BEHAVIORAL

Patients will be given 30 grams of corn starch

Interventions

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Resistant starch

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

Intervention Type DIETARY_SUPPLEMENT

Exercise

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

Intervention Type BEHAVIORAL

Starch

Patients will be given 30 grams of corn starch

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No