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

University of Illinois at Urbana-Champaign

Status and phase

Completed

Early Phase 1

Conditions

Bone Diseases, Endocrine

Nutritional and Metabolic Diseases

Treatments

Dietary Supplement: Maltodextrin

Dietary Supplement: Inulin

Study type

Interventional

Funder types

Other

Identifiers

NCT02718885

16035

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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.