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NCT Number: NCT05071131

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

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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Key information

Conditions

Chronic Kidney Disease 5D

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inulin

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. Plasma concentration of Zonulin-1

    Time frame: After 35 days compared to placebo

    Measured by ELISA [ng/ml]

Secondary outcomes

  1. Plasma concentration of soluble CD14

    Time frame: After 35 days compared to placebo

    Measured by ELISA [ng/ml]

  2. Short-chain fatty acid-associated bacterial gene expression

    Time frame: After 35 days compared to placebo and adjusted for baseline

    Measured by quantitative PCR

  3. Short-chain fatty acid-associated gene expression in immune cells

    Time frame: After 35 days compared to placebo

    Measured by quantitative PCR

  4. Indole-associated bacterial gene expression

    Time frame: After 35 days compared to placebo

    Measured by quantitative PCR

  5. Indole-associated gene expression in immune cells

    Time frame: After 35 days compared to placebo

    Measured by quantitative PCR

  6. Fecal metabolome

    Time frame: After 35 days compared to placebo and adjusted for baseline

    Measured by mass spectrometry

  7. Serum metabolome

    Time frame: After 35 days compared to placebo

    Measured by mass spectrometry

  8. Serum concentration of Trimethylamine-N-Oxide (TMAO)

    Time frame: After 35 days compared to placebo

    Measured by LC-MS [µM]

  9. Fecal microbiome taxonomy

    Time frame: After 35 days compared to placebo

    Measured by 16S amplicon sequencing

  10. Activation potential of aryl hydrocarbon receptor (AhR) in serum

    Time frame: After 35 days compared to placebo and adjusted for baseline

    Measured by cell-based luciferase reporter assay (delta luminescence)

  11. Frequency of circulating T-cell subtypes

    Time frame: After 35 days compared to placebo

    Measured by flow cytometry (%)

  12. Office systolic blood pressure

    Time frame: After 35 days compared to placebo

    Mean of five consecutive blood pressure measurements (mmHg)

  13. Office diastolic blood pressure

    Time frame: After 35 days compared to placebo

    Mean of five consecutive blood pressure measurements (mmHg)

  14. Plasma concentration of IL-1

    Time frame: After 35 days compared to placebo

    Measured by ELISA [pg/ml]

  15. Plasma concentration of IL-6

    Time frame: After 35 days compared to placebo

    Measured by ELISA [pg/ml]

  16. Plasma concentration of TNF-alpha

    Time frame: After 35 days compared to placebo

    Measured by ELISA [pg/ml]

  17. Creatinine

    Time frame: After 35 days compared to placebo

    Creatine serum concentration

  18. Cystatin c

    Time frame: After 35 days compared to placebo

    Cystatin c serum concentration

  19. Creatinine / cystatin c ratio

    Time frame: After 35 days compared to placebo

    Measured in serum

Study contacts

Contact information is provided by the study sponsor or research team.

Victoria McParland, PhD

CONTACT

[email protected]

+49 30 450 540 464

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Investigating the Effect of Inulin on Gut Microbiota and Gut Barrier in Advanced Chronic Kidney Disease - a Randomised, Placebo-controlled Trial

Acronym: RESTORE

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Oct 8, 2021
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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