Chronic Kidney Disease 5D
Conditions
Keywords
Hemodialysis, Fiber, Zonulin, Short chain fatty acids, Dietary analysis
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTInulin
1 sachet à 15 grams daily for 7 days, followed by 2 sachets à 15 grams daily for 28 days
DIETARY_SUPPLEMENTPlacebo
1 sachet à 15 grams daily for 7 days, followed by 2 sachets à 15 grams daily for 28 days
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Men and women in a ratio of 1:1 * Age 18-75 years * Body mass index 25.0 - 39.9 kg/m\^2 * End-stage kidney disease, which has been treated regularly with hemodialysis for at least 3 months
Exclusion criteria
* Malignant diseases * Recent or current hospitalization * Postoperative phase * Acute infections * Malnutrition * Antibiotic treatment within the last 4 weeks * Regular intake of probiotics and/or prebiotics * Change of body weight of more than 2 kg in the month prior to study entry * Known drug or alcohol abuse Changes applied in July 2022 according to amendment no. 1: * Two inclusion criteria were changed to improve recruitment * Age range was changed from 18-70 to 18-75 years * BMI range was changed from 18.5 - 34.9 to 25.0 - 39.9 kg/m\^2 * The intervention scheme was adapted to increase patient adherence * A 7-day adaption phase with half of the dose (15 grams per day) at the start of the intervention was introduced, changing treatment duration from 28 to 35 days Changes applied in January 2024 according to amendment no. 2: * One inclusion criteria was changed to improve recruitment * BMI range was changed from 25 - 39,9 to 18,5 - 39,9 kg/m² * Last visit was brought foward by 4 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration of Zonulin-1 | After 35 days compared to placebo | Measured by ELISA \[ng/ml\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short-chain fatty acid-associated bacterial gene expression | After 35 days compared to placebo and adjusted for baseline | Measured by quantitative PCR |
| Short-chain fatty acid-associated gene expression in immune cells | After 35 days compared to placebo | Measured by quantitative PCR |
| Indole-associated bacterial gene expression | After 35 days compared to placebo | Measured by quantitative PCR |
| Indole-associated gene expression in immune cells | After 35 days compared to placebo | Measured by quantitative PCR |
| Fecal metabolome | After 35 days compared to placebo and adjusted for baseline | Measured by mass spectrometry |
| Serum metabolome | After 35 days compared to placebo | Measured by mass spectrometry |
| Serum concentration of Trimethylamine-N-Oxide (TMAO) | After 35 days compared to placebo | Measured by LC-MS \[µM\] |
| Fecal microbiome taxonomy | After 35 days compared to placebo | Measured by 16S amplicon sequencing |
| Activation potential of aryl hydrocarbon receptor (AhR) in serum | After 35 days compared to placebo and adjusted for baseline | Measured by cell-based luciferase reporter assay (delta luminescence) |
| Plasma concentration of soluble CD14 | After 35 days compared to placebo | Measured by ELISA \[ng/ml\] |
| Office systolic blood pressure | After 35 days compared to placebo | Mean of five consecutive blood pressure measurements (mmHg) |
| Office diastolic blood pressure | After 35 days compared to placebo | Mean of five consecutive blood pressure measurements (mmHg) |
| Plasma concentration of IL-1 | After 35 days compared to placebo | Measured by ELISA \[pg/ml\] |
| Plasma concentration of IL-6 | After 35 days compared to placebo | Measured by ELISA \[pg/ml\] |
| Plasma concentration of TNF-alpha | After 35 days compared to placebo | Measured by ELISA \[pg/ml\] |
| Creatinine | After 35 days compared to placebo | Creatine serum concentration |
| Cystatin c | After 35 days compared to placebo | Cystatin c serum concentration |
| Creatinine / cystatin c ratio | After 35 days compared to placebo | Measured in serum |
| Frequency of circulating T-cell subtypes | After 35 days compared to placebo | Measured by flow cytometry (%) |
Countries
Germany
Contacts
Primary ContactVictoria McParland, PhD
Outcome results
None listed