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

Primary Purpose

Chronic Kidney Disease 5D

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Inulin
Placebo
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Kidney Disease 5D focused on measuring Hemodialysis, Fiber, Zonulin, Short chain fatty acids, Dietary analysis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Experimental and Clinical Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Inulin

Placebo

Arm Description

15 grams inulin per day for 7 days, followed by 30 grams inulin per day for 28 days

15 grams maltodextrin per day for 7 days, followed by 30 grams maltodextrin per day for 28 days

Outcomes

Primary Outcome Measures

Plasma concentration of Zonulin-1
Measured by ELISA [ng/ml]

Secondary Outcome Measures

Plasma concentration of soluble CD14
Measured by ELISA [ng/ml]
Short-chain fatty acid-associated bacterial gene expression
Measured by quantitative PCR
Short-chain fatty acid-associated gene expression in immune cells
Measured by quantitative PCR
Indole-associated bacterial gene expression
Measured by quantitative PCR
Indole-associated gene expression in immune cells
Measured by quantitative PCR
Fecal metabolome
Measured by mass spectrometry
Serum metabolome
Measured by mass spectrometry
Serum concentration of Trimethylamine-N-Oxide (TMAO)
Measured by LC-MS [µM]
Fecal microbiome taxonomy
Measured by 16S amplicon sequencing
Activation potential of aryl hydrocarbon receptor (AhR) in serum
Measured by cell-based luciferase reporter assay (delta luminescence)
Frequency of circulating T-cell subtypes
Measured by flow cytometry (%)
Office systolic blood pressure
Mean of five consecutive blood pressure measurements (mmHg)
Office diastolic blood pressure
Mean of five consecutive blood pressure measurements (mmHg)
Plasma concentration of IL-1
Measured by ELISA [pg/ml]
Plasma concentration of IL-6
Measured by ELISA [pg/ml]
Plasma concentration of TNF-alpha
Measured by ELISA [pg/ml]
Creatinine
Creatine serum concentration
Cystatin c
Cystatin c serum concentration
Creatinine / cystatin c ratio
Measured in serum

Full Information

First Posted
September 16, 2021
Last Updated
February 7, 2023
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT05071131
Brief Title
Effect of Inulin on Gut Microbiota and Gut Barrier in Chronic Kidney Disease
Acronym
RESTORE
Official Title
Investigating the Effect of Inulin on Gut Microbiota and Gut Barrier in Advanced Chronic Kidney Disease - a Randomised, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease 5D
Keywords
Hemodialysis, Fiber, Zonulin, Short chain fatty acids, Dietary analysis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inulin
Arm Type
Active Comparator
Arm Description
15 grams inulin per day for 7 days, followed by 30 grams inulin per day for 28 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
15 grams maltodextrin per day for 7 days, followed by 30 grams maltodextrin per day for 28 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Inulin
Intervention Description
1 sachet à 15 grams daily for 7 days, followed by 2 sachets à 15 grams daily for 28 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
1 sachet à 15 grams daily for 7 days, followed by 2 sachets à 15 grams daily for 28 days
Primary Outcome Measure Information:
Title
Plasma concentration of Zonulin-1
Description
Measured by ELISA [ng/ml]
Time Frame
After 35 days compared to placebo
Secondary Outcome Measure Information:
Title
Plasma concentration of soluble CD14
Description
Measured by ELISA [ng/ml]
Time Frame
After 35 days compared to placebo
Title
Short-chain fatty acid-associated bacterial gene expression
Description
Measured by quantitative PCR
Time Frame
After 35 days compared to placebo and adjusted for baseline
Title
Short-chain fatty acid-associated gene expression in immune cells
Description
Measured by quantitative PCR
Time Frame
After 35 days compared to placebo
Title
Indole-associated bacterial gene expression
Description
Measured by quantitative PCR
Time Frame
After 35 days compared to placebo
Title
Indole-associated gene expression in immune cells
Description
Measured by quantitative PCR
Time Frame
After 35 days compared to placebo
Title
Fecal metabolome
Description
Measured by mass spectrometry
Time Frame
After 35 days compared to placebo and adjusted for baseline
Title
Serum metabolome
Description
Measured by mass spectrometry
Time Frame
After 35 days compared to placebo
Title
Serum concentration of Trimethylamine-N-Oxide (TMAO)
Description
Measured by LC-MS [µM]
Time Frame
After 35 days compared to placebo
Title
Fecal microbiome taxonomy
Description
Measured by 16S amplicon sequencing
Time Frame
After 35 days compared to placebo
Title
Activation potential of aryl hydrocarbon receptor (AhR) in serum
Description
Measured by cell-based luciferase reporter assay (delta luminescence)
Time Frame
After 35 days compared to placebo and adjusted for baseline
Title
Frequency of circulating T-cell subtypes
Description
Measured by flow cytometry (%)
Time Frame
After 35 days compared to placebo
Title
Office systolic blood pressure
Description
Mean of five consecutive blood pressure measurements (mmHg)
Time Frame
After 35 days compared to placebo
Title
Office diastolic blood pressure
Description
Mean of five consecutive blood pressure measurements (mmHg)
Time Frame
After 35 days compared to placebo
Title
Plasma concentration of IL-1
Description
Measured by ELISA [pg/ml]
Time Frame
After 35 days compared to placebo
Title
Plasma concentration of IL-6
Description
Measured by ELISA [pg/ml]
Time Frame
After 35 days compared to placebo
Title
Plasma concentration of TNF-alpha
Description
Measured by ELISA [pg/ml]
Time Frame
After 35 days compared to placebo
Title
Creatinine
Description
Creatine serum concentration
Time Frame
After 35 days compared to placebo
Title
Cystatin c
Description
Cystatin c serum concentration
Time Frame
After 35 days compared to placebo
Title
Creatinine / cystatin c ratio
Description
Measured in serum
Time Frame
After 35 days compared to placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria McParland, PhD
Phone
+49 30 450 540 464
Email
victoria.mcparland@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anja Mähler, PhD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicola Wilck, MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Victoria McParland, PhD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Johannes Holle, MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Experimental and Clinical Research Center
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria McParland, PhD
Phone
+4930450540464
Email
victoria.mcparland@charite.de
First Name & Middle Initial & Last Name & Degree
Nicola Wilck, MD
Phone
+4930450540459
Email
nicola.wilck@charite.de

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal.

Learn more about this trial

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

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