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OpenTrials
Completed

NCT Number: NCT03689569

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

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistant starch

Dietary Supplement

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

Exercise

Behavioral

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

Starch

Behavioral

Patients will be given 30 grams of corn starch

Primary outcomes

  1. Change in hs CRP

    Time frame: baseline and after 16 weeks

    hsCRP

  2. Change in TNF alpha

    Time frame: Baseline and at week 16

    TNFalpha

  3. Change in IL6

    Time frame: Baseline and at week 16

    IL6

  4. Change in IL10

    Time frame: Baseline and at week 16

    IL10

  5. Change in MCP1

    Time frame: Baseline and at week 16

    MCP1

Secondary outcomes

  1. Change in vascular function

    Time frame: Baseline, week 8 and week 16

    Pulse wave velocity

  2. Change in microbiome composition

    Time frame: Baseline and after 16 weeks

    The composition of the microbiome will be assessed at baseline and after 16 weeks

  3. Change in blood pressure

    Time frame: Baseline & after 16 weeks

    central blood pressure

Sponsors and collaborators

Lead sponsor

Springfield College

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 28, 2018
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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