Chronic Kidney Disease 5DRESTORENCT05071131
Effect of Inulin on Gut Microbiota and Gut Barrier in Chronic Kidney Disease
A study testing Inulin in people with Chronic Kidney Disease 5D, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Disease 5D
- What is being tested?
- Inulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2022to 1 Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Malignant diseases
- Recent or current hospitalization
- Postoperative phase
- Acute infections
- Malnutrition
- Antibiotic treatment within the last 4 weeks
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Experimental and Clinical Research Center
Berlin, 13125
Victoria McParland, PhD, +4930450540464, victoria.mcparland@charite.de
Nicola Wilck, MD, +4930450540459, nicola.wilck@charite.de
About this study
Official title: Investigating the Effect of Inulin on Gut Microbiota and Gut Barrier in Advanced Chronic Kidney Disease - a Randomised, Placebo-controlled Trial
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.
- Conditions
- Chronic Kidney Disease 5D
- Being tested
- Inulin, Placebo
- Keywords
- Hemodialysis, Fiber, Zonulin, Short chain fatty acids, Dietary analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InulinDietary supplement
1 sachet à 15 grams daily for 7 days, followed by 2 sachets à 15 grams daily for 28 days
PlaceboDietary supplement
1 sachet à 15 grams daily for 7 days, followed by 2 sachets à 15 grams daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Inulin | Active comparator | 15 grams inulin per day for 7 days, followed by 30 grams inulin per day for 28 days Receives: Dietary Supplement: Inulin |
| Placebo | Placebo comparator | 15 grams maltodextrin per day for 7 days, followed by 30 grams maltodextrin per day for 28 days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of Zonulin-1
Measured by ELISA [ng/ml]
Measured: After 35 days compared to placebo
Secondary outcomes (19)
Plasma concentration of soluble CD14
Measured by ELISA [ng/ml]
Measured: After 35 days compared to placebo
Short-chain fatty acid-associated bacterial gene expression
Measured by quantitative PCR
Measured: After 35 days compared to placebo and adjusted for baseline
Short-chain fatty acid-associated gene expression in immune cells
Measured by quantitative PCR
Measured: After 35 days compared to placebo
Indole-associated bacterial gene expression
Measured by quantitative PCR
Measured: After 35 days compared to placebo
Indole-associated gene expression in immune cells
Measured by quantitative PCR
Measured: After 35 days compared to placebo
Fecal metabolome
Measured by mass spectrometry
Measured: After 35 days compared to placebo and adjusted for baseline
Serum metabolome
Measured by mass spectrometry
Measured: After 35 days compared to placebo
Serum concentration of Trimethylamine-N-Oxide (TMAO)
Measured by LC-MS [µM]
Measured: After 35 days compared to placebo
Fecal microbiome taxonomy
Measured by 16S amplicon sequencing
Measured: After 35 days compared to placebo
Activation potential of aryl hydrocarbon receptor (AhR) in serum
Measured by cell-based luciferase reporter assay (delta luminescence)
Measured: After 35 days compared to placebo and adjusted for baseline
Frequency of circulating T-cell subtypes
Measured by flow cytometry (%)
Measured: After 35 days compared to placebo
Office systolic blood pressure
Mean of five consecutive blood pressure measurements (mmHg)
Measured: After 35 days compared to placebo
Office diastolic blood pressure
Mean of five consecutive blood pressure measurements (mmHg)
Measured: After 35 days compared to placebo
Plasma concentration of IL-1
Measured by ELISA [pg/ml]
Measured: After 35 days compared to placebo
Plasma concentration of IL-6
Measured by ELISA [pg/ml]
Measured: After 35 days compared to placebo
Plasma concentration of TNF-alpha
Measured by ELISA [pg/ml]
Measured: After 35 days compared to placebo
Creatinine
Creatine serum concentration
Measured: After 35 days compared to placebo
Cystatin c
Cystatin c serum concentration
Measured: After 35 days compared to placebo
Creatinine / cystatin c ratio
Measured in serum
Measured: After 35 days compared to placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start1 Feb 2022
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease 5DStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Till Schütte, Charite University, Berlin, Germany
- Investigators
- Anja Mähler, PhD, Principal investigator, Charite University, Berlin, GermanyNicola Wilck, MD, Principal investigator, Charite University, Berlin, GermanyVictoria McParland, PhD, Principal investigator, Charite University, Berlin, GermanyJohannes Holle, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071131
- Sponsor's protocol ID
- RESTORE
- Acronym
- RESTORE
- Status last verified
- Jun 2024
- First submitted
- 16 Sep 2021
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.