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

NCT05071131 | Recruiting

• 1 other identifier: RESTORE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease 5D

Keywords

Hemodialysis; Fiber; Zonulin; Short chain fatty acids; Dietary analysis

Outcome Measures

Primary Outcomes (1)

• Plasma concentration of Zonulin-1

  Measured by ELISA \[ng/ml\]

  After 35 days compared to placebo

Secondary Outcomes (19)

• Plasma concentration of soluble CD14

  After 35 days compared to placebo

• Short-chain fatty acid-associated bacterial gene expression

  After 35 days compared to placebo and adjusted for baseline

• Short-chain fatty acid-associated gene expression in immune cells

  After 35 days compared to placebo

• Indole-associated bacterial gene expression

  After 35 days compared to placebo

• Indole-associated gene expression in immune cells

  After 35 days compared to placebo

Study Arms (2)

Inulin

ACTIVE COMPARATOR

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

Dietary Supplement: Inulin

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Inulin DIETARY_SUPPLEMENT

1 sachet à 15 grams daily for 7 days, followed by 2 sachets à 15 grams daily for 28 days

Inulin

Placebo DIETARY_SUPPLEMENT

1 sachet à 15 grams daily for 7 days, followed by 2 sachets à 15 grams daily for 28 days

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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:

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Experimental and Clinical Research Center

Berlin, 13125, Germany

RECRUITING

MeSH Terms

Interventions

Inulin

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Study Officials

• Anja Mähler, PhD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Nicola Wilck, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Victoria McParland, PhD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Johannes Holle, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria McParland, PhD

CONTACT

+49 30 450 540 464; victoria.mcparland@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: October 8, 2021
• Study Start: February 1, 2022
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

DE (1)