Effect of Inulin on Gut Microbiota and Gut Barrier in Chronic Kidney Disease

Not Applicable

Recruiting

• Conditions: Chronic Kidney Disease 5D
• Interventions: Dietary Supplement: Inulin; Dietary Supplement: Placebo

• Registration Number: NCT05071131
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-16
• Study First Submitted QC: 2021-09-27
• Study First Posted: 2021-10-08
• Study Start: 2022-02-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-25
• Primary Completion: 2026-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inulin	Inulin	15 grams inulin per day for 7 days, followed by 30 grams inulin per day for 28 days
Placebo	Placebo	15 grams maltodextrin per day for 7 days, followed by 30 grams maltodextrin per day for 28 days

Primary Outcome Measures

Name	Time	Method
Plasma concentration of Zonulin-1	After 35 days compared to placebo	Measured by ELISA \[ng/ml\]

Secondary Outcome Measures

Name	Time	Method
Plasma concentration of IL-6	After 35 days compared to placebo	Measured by ELISA \[pg/ml\]
Cystatin c	After 35 days compared to placebo	Cystatin c serum concentration
Short-chain fatty acid-associated bacterial gene expression	After 35 days compared to placebo and adjusted for baseline	Measured by quantitative PCR
Serum concentration of Trimethylamine-N-Oxide (TMAO)	After 35 days compared to placebo	Measured by LC-MS \[µM\]
Creatinine	After 35 days compared to placebo	Creatine serum concentration
Plasma concentration of soluble CD14	After 35 days compared to placebo	Measured by ELISA \[ng/ml\]
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
Creatinine / cystatin c ratio	After 35 days compared to placebo	Measured in serum
Fecal microbiome taxonomy	After 35 days compared to placebo	Measured by 16S amplicon sequencing
Fecal metabolome	After 35 days compared to placebo and adjusted for baseline	Measured by mass spectrometry
Frequency of circulating T-cell subtypes	After 35 days compared to placebo	Measured by flow cytometry (%)
Plasma concentration of IL-1	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 \[pg/ml\]
Indole-associated gene expression in immune cells	After 35 days compared to placebo	Measured by quantitative PCR
Serum metabolome	After 35 days compared to placebo	Measured by mass spectrometry
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)
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)

Trial Locations

Locations (1)

Experimental and Clinical Research Center; 🇩🇪 Berlin, Germany