Trials / Unknown
UnknownNCT03689569
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Springfield College · Academic / Other
- Sex
- All
- Age
- 30 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-09-18
- Primary completion
- 2021-05-31
- Completion
- 2021-08-31
- First posted
- 2018-09-28
- Last updated
- 2018-10-09
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03689569. Inclusion in this directory is not an endorsement.