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

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03689569
• Other study ID #: Prebiotic study
• Status: Recruiting
• Phase: N/A
• Start date: September 18, 2018
• Est. completion date: August 31, 2021

Study information

• Verified date: October 2018
• Source: Springfield College
• Contact: Samuel A Headley, PhD
• Phone: 413-748-3340
• Email: sheadley[@]springfieldcollege.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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
• Starch
Patients will be given 30 grams of corn starch

Locations

Country	Name	City	State
United States	Springfield College	Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Springfield College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hs CRP	hsCRP	baseline and after 16 weeks
Primary	Change in TNF alpha	TNFalpha	Baseline and at week 16
Primary	Change in IL6	IL6	Baseline and at week 16
Primary	Change in IL10	IL10	Baseline and at week 16
Primary	Change in MCP1	MCP1	Baseline and at week 16
Secondary	Change in vascular function	Pulse wave velocity	Baseline, week 8 and week 16
Secondary	Change in microbiome composition	The composition of the microbiome will be assessed at baseline and after 16 weeks	Baseline and after 16 weeks
Secondary	Change in blood pressure	central blood pressure	Baseline & after 16 weeks