Gut Microbiome Mediated Effects of Inulin Supplementation on Mineral and Bone Metabolism in Hemodialysis Patients

Early Phase 1

Completed

• Conditions: Bone Diseases, Endocrine; Nutritional and Metabolic Diseases
• Interventions: Dietary Supplement: Inulin; Dietary Supplement: Maltodextrin

• Registration Number: NCT02718885
• Lead Sponsor: University of Illinois at Urbana-Champaign

Brief Summary

The overall objective of the study is to examine the changes within the gut microbiome after the supplementation of inulin and its effect on markers of mineral metabolism and bone turnover.

Detailed Description

In this randomized controlled cross-over study, twenty HD patients (10 male/10 female, aged 20-80) will be recruited from local dialysis clinics in Champaign-Urbana, IL. After baseline testing, patients will be randomized to the intervention group or placebo group (maltodextrin). Patients will consume inulin (females 10g/day, males 15g/day) or maltodextrin (females 10g/day, males 15g/day) for one month, rest for two weeks (washout period), and continue with the other treatment (either inulin or maltodextrin) for another month. Outcomes will be assessed at the beginning of each period and after a month of supplementation at both periods.

Study Timeline

• Study First Submitted: 2016-03-18
• Study First Submitted QC: 2016-03-18
• Study First Posted: 2016-03-24
• Study Start: 2016-05
• Primary Completion: 2017-12
• Status Verified: 2018-07
• Study Completion: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Receive HD therapy 3 days per week and for at least 3 months

Exclusion Criteria

• Sustained hypercalcemia (>3months).
• Previous major gastrointestinal disease diagnosis (e.g., inflammatory bowel disease and celiac disease).
• Antibiotic treatment < 2 weeks prior the start of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Inulin	Inulin	Inulin-type fructans
Maltodextrin	Maltodextrin	Maltodextrin

Primary Outcome Measures

Name	Time	Method
Mineral metabolism	4 weeks	Plasma calcium, phosphorus and magnesium will be assessed by an blood-chemistry autoanalyzer at the beginning and end of each supplementation period. Additionally, parathyroid hormone and fibroblast-growth factor will be assessed by ELISA.

Secondary Outcome Measures

Name	Time	Method
Gut microbiome	4 weeks	Participants will be asked to collect a complete fecal sample at the beginning and end of Period 1 and 2. V4 regions of the bacterial 16S rRNA gene will be isolated and amplified. Sequencing will be done through Illumina Mi-seq V3 platform. General changes in bacterial diversity and taxa will be analyzed through the open software QIIME.
Gut-microbiota derived metabolites	4 weeks	Free serum p-cresyl sulfate and indoxyl sulfate: serum (4ml) will be collected on midweek dialysis session and analyzed using an HPLC.
Bone biomarkers	4 weeks	Sclerostin, bone-specific alkaline phosphatase and osteoprotegerin will be assessed by ELISA kits at the beginning and end of each period

Trial Locations

Locations (1)

University of Illinois at Urbana-Champaign; 🇺🇸 Urbana, Illinois, United States