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PRebiotic to IMprovE Calcium Absorption

NCT03272542 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-10-22

No results posted yet for this study

Summary

Gastric bypass surgery is a highly effective treatment for obesity, but it has negative effects on skeletal health, due in part to a dramatic decline in intestinal calcium absorption capacity. Animal and human studies suggest that non-digestible fibers termed prebiotics, such as soluble corn fiber (SCF), augment calcium absorption in the lower intestine as they act as substrates for beneficial gut microbiota. This is a pilot randomized controlled trial of the effects of SCF vs. placebo on intestinal calcium absorption, bone turnover marker levels, and the gut microbiome in postmenopausal women who have previously undergone gastric bypass surgery.

Conditions

Interventions

DIETARY_SUPPLEMENT

Prebiotic: soluble corn fiber

prebiotic

DIETARY_SUPPLEMENT

Placebo: maltodextrin

placebo

Sponsors & Collaborators

  • University of California, San Francisco

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • San Francisco Veterans Affairs Medical Center

    lead FED

Principal Investigators

  • Anne Schafer, MD · UCSF & SFVAMC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-21
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03272542 on ClinicalTrials.gov