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Trial record 10 of 227 for:    Intestinal | maltodextrin

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

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ClinicalTrials.gov Identifier: NCT02718885
Recruitment Status : Completed
First Posted : March 24, 2016
Last Update Posted : August 2, 2018
Sponsor:
Collaborator:
Renal Research Institute
Information provided by (Responsible Party):
Kenneth Wilund, 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.

Condition or disease Intervention/treatment Phase
Bone Diseases, Endocrine Nutritional and Metabolic Diseases Dietary Supplement: Inulin Dietary Supplement: Maltodextrin Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Gut Microbiome Mediated Effects of Inulin Supplementation on Mineral and Bone Metabolism in Hemodialysis Patients
Actual Study Start Date : May 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Minerals
Drug Information available for: Inulin

Arm Intervention/treatment
Sham Comparator: Maltodextrin
Maltodextrin
Dietary Supplement: Maltodextrin
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

Active Comparator: Inulin
Inulin-type fructans
Dietary Supplement: Inulin
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
Other Name: Inulin-type fructans




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02718885


Locations
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United States, Illinois
University of Illinois at Urbana-Champaign
Urbana, Illinois, United States, 61801
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Renal Research Institute
Investigators
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Principal Investigator: Kenneth Wilund, Ph.D. University of Illinois at Urbana-Champaign

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Responsible Party: Kenneth Wilund, Associate Professor, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT02718885     History of Changes
Other Study ID Numbers: 16035
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kenneth Wilund, University of Illinois at Urbana-Champaign:
inulin-type fructans
hemodialysis
gut microbiome
mineral and bone disorder
Additional relevant MeSH terms:
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Bone Diseases
Bone Diseases, Endocrine
Metabolic Diseases
Endocrine System Diseases
Musculoskeletal Diseases
Levan
Antineoplastic Agents