An adequate fiber intake is crucial for a well-balanced diet and reduces the risk of chronic diseases. However, nutritional recommendations for chronic kidney disease patients lead to an insufficient fiber intake with possible maladaptive effects on the gut microbiome. Therefore, we want to study the effects of a 35-day inulin supplementation on the gut microbiome, gut barrier function, bacterial metabolites and immune cell states in chronic kidney disease patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
40
Experimental and Clinical Research Center
Berlin, Germany
RECRUITINGPlasma concentration of Zonulin-1
Measured by ELISA \[ng/ml\]
Time frame: After 35 days compared to placebo
Plasma concentration of soluble CD14
Measured by ELISA \[ng/ml\]
Time frame: After 35 days compared to placebo
Short-chain fatty acid-associated bacterial gene expression
Measured by quantitative PCR
Time frame: After 35 days compared to placebo and adjusted for baseline
Short-chain fatty acid-associated gene expression in immune cells
Measured by quantitative PCR
Time frame: After 35 days compared to placebo
Indole-associated bacterial gene expression
Measured by quantitative PCR
Time frame: After 35 days compared to placebo
Indole-associated gene expression in immune cells
Measured by quantitative PCR
Time frame: After 35 days compared to placebo
Fecal metabolome
Measured by mass spectrometry
Time frame: After 35 days compared to placebo and adjusted for baseline
Serum metabolome
Measured by mass spectrometry
Time frame: After 35 days compared to placebo
Serum concentration of Trimethylamine-N-Oxide (TMAO)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Measured by LC-MS \[µM\]
Time frame: After 35 days compared to placebo
Fecal microbiome taxonomy
Measured by 16S amplicon sequencing
Time frame: After 35 days compared to placebo
Activation potential of aryl hydrocarbon receptor (AhR) in serum
Measured by cell-based luciferase reporter assay (delta luminescence)
Time frame: After 35 days compared to placebo and adjusted for baseline
Frequency of circulating T-cell subtypes
Measured by flow cytometry (%)
Time frame: After 35 days compared to placebo
Office systolic blood pressure
Mean of five consecutive blood pressure measurements (mmHg)
Time frame: After 35 days compared to placebo
Office diastolic blood pressure
Mean of five consecutive blood pressure measurements (mmHg)
Time frame: After 35 days compared to placebo
Plasma concentration of IL-1
Measured by ELISA \[pg/ml\]
Time frame: After 35 days compared to placebo
Plasma concentration of IL-6
Measured by ELISA \[pg/ml\]
Time frame: After 35 days compared to placebo
Plasma concentration of TNF-alpha
Measured by ELISA \[pg/ml\]
Time frame: After 35 days compared to placebo
Creatinine
Creatine serum concentration
Time frame: After 35 days compared to placebo
Cystatin c
Cystatin c serum concentration
Time frame: After 35 days compared to placebo
Creatinine / cystatin c ratio
Measured in serum
Time frame: After 35 days compared to placebo