Gut Microbiome Mediated Effects of Inulin Supplementation on Mineral and Bone Metabolism in Hemodialysis Patients
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started May 2016
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2016
CompletedFirst Posted
Study publicly available on registry
March 24, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedAugust 2, 2018
July 1, 2018
1.6 years
March 18, 2016
July 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mineral metabolism
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.
4 weeks
Secondary Outcomes (3)
Bone biomarkers
4 weeks
Gut-microbiota derived metabolites
4 weeks
Gut microbiome
4 weeks
Study Arms (2)
Maltodextrin
SHAM COMPARATORMaltodextrin
Inulin
ACTIVE COMPARATORInulin-type fructans
Interventions
Females will ingest 2 doses of 5g/inulin for a total of 10g/inulin/day for four weeks Males will ingest 2 doses of 7.5g/inulin for a total of 15g/inulin/day for four weeks
Females will ingest 2 doses of 5g/maltodextrin for a total of 10g/maltodextrin/day for four weeks Males will ingest 2 doses of 7.5g/maltodextrin for a total of 15g/maltodextrin/day for four weeks
Eligibility Criteria
You may qualify if:
- Receive HD therapy 3 days per week and for at least 3 months
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth Wilund, Ph.D.
University of Illinois at Urbana-Champaign
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 18, 2016
First Posted
March 24, 2016
Study Start
May 1, 2016
Primary Completion
December 1, 2017
Study Completion
July 1, 2018
Last Updated
August 2, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share