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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: University of Illinois at Urbana-Champaign

Current Primary Outcome: Mineral metabolism [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Bone biomarkers [ Time Frame: 4 weeks ]
    Sclerostin, bone-specific alkaline phosphatase and osteoprotegerin will be assessed by ELISA kits at the beginning and end of each period
  • Gut-microbiota derived metabolites [ Time Frame: 4 weeks ]
    Free serum p-cresyl sulfate and indoxyl sulfate: serum (4ml) will be collected on midweek dialysis session and analyzed using an HPLC.
  • Gut microbiome [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: University of Illinois at Urbana-Champaign

Dates:
Date Received: March 18, 2016
Date Started: May 2016
Date Completion: August 2017
Last Updated: May 10, 2016
Last Verified: May 2016