NCT02718885

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Illinois at Urbana-Champaign · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bone Diseases, Endocrine
• Nutritional and Metabolic Diseases

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-12-01
• Completion: 2018-07-01
• First posted: 2016-03-24
• Last updated: 2018-08-02

Locations

1 site across 1 country: United States