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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inulin | Active Comparator | 15 grams inulin per day for 7 days, followed by 30 grams inulin per day for 28 days |
|
| Placebo | Placebo Comparator | 15 grams maltodextrin per day for 7 days, followed by 30 grams maltodextrin per day for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inulin | Dietary Supplement | 1 sachet à 15 grams daily for 7 days, followed by 2 sachets à 15 grams daily for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of Zonulin-1 | Measured by ELISA [ng/ml] | After 35 days compared to placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of soluble CD14 | Measured by ELISA [ng/ml] | After 35 days compared to placebo |
| Short-chain fatty acid-associated bacterial gene expression | Measured by quantitative PCR |
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Inclusion Criteria:
Exclusion Criteria:
Changes applied in July 2022 according to amendment no. 1:
Two inclusion criteria were changed to improve recruitment
The intervention scheme was adapted to increase patient adherence
Changes applied in January 2024 according to amendment no. 2:
One inclusion criteria was changed to improve recruitment
Last visit was brought foward by 4 weeks.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victoria McParland, PhD | Contact | +49 30 450 540 464 | victoria.mcparland@charite.de |
| Name | Affiliation | Role |
|---|---|---|
| Anja Mähler, PhD | Charite University, Berlin, Germany | Principal Investigator |
| Nicola Wilck, MD | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Experimental and Clinical Research Center | Recruiting | Berlin | 13125 | Germany |
Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.
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Beginning 9 months and ending 36 months following article publication.
Researchers who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D007444 | Inulin |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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| Placebo | Dietary Supplement | 1 sachet à 15 grams daily for 7 days, followed by 2 sachets à 15 grams daily for 28 days |
|
| After 35 days compared to placebo and adjusted for baseline |
| Short-chain fatty acid-associated gene expression in immune cells | Measured by quantitative PCR | After 35 days compared to placebo |
| Indole-associated bacterial gene expression | Measured by quantitative PCR | After 35 days compared to placebo |
| Indole-associated gene expression in immune cells | Measured by quantitative PCR | After 35 days compared to placebo |
| Fecal metabolome | Measured by mass spectrometry | After 35 days compared to placebo and adjusted for baseline |
| Serum metabolome | Measured by mass spectrometry | After 35 days compared to placebo |
| Serum concentration of Trimethylamine-N-Oxide (TMAO) | Measured by LC-MS [µM] | After 35 days compared to placebo |
| Fecal microbiome taxonomy | Measured by 16S amplicon sequencing | After 35 days compared to placebo |
| Activation potential of aryl hydrocarbon receptor (AhR) in serum | Measured by cell-based luciferase reporter assay (delta luminescence) | After 35 days compared to placebo and adjusted for baseline |
| Frequency of circulating T-cell subtypes | Measured by flow cytometry (%) | After 35 days compared to placebo |
| Office systolic blood pressure | Mean of five consecutive blood pressure measurements (mmHg) | After 35 days compared to placebo |
| Office diastolic blood pressure | Mean of five consecutive blood pressure measurements (mmHg) | After 35 days compared to placebo |
| Plasma concentration of IL-1 | Measured by ELISA [pg/ml] | After 35 days compared to placebo |
| Plasma concentration of IL-6 | Measured by ELISA [pg/ml] | After 35 days compared to placebo |
| Plasma concentration of TNF-alpha | Measured by ELISA [pg/ml] | After 35 days compared to placebo |
| Creatinine | Creatine serum concentration | After 35 days compared to placebo |
| Cystatin c | Cystatin c serum concentration | After 35 days compared to placebo |
| Creatinine / cystatin c ratio | Measured in serum | After 35 days compared to placebo |
| Victoria McParland, PhD |
| Charite University, Berlin, Germany |
| Principal Investigator |
| Johannes Holle, MD | Charite University, Berlin, Germany | Principal Investigator |
| Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |