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Investigation of the Ability of a Supplement to Increase Good Bacteria in the Human Intestine and Blood Sugar Levels

NCT01944904 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2017-03-01

No results posted yet for this study

Summary

This study aims to determine whether the use of a supplement called xylooligosaccharide (XOS) increases the number of good bacteria that live in human intestines and can maintain healthy blood sugar levels, and whether XOS has any unpleasant or unexpected side effects when consumed at different dosages. Subjects who participate in this study will be randomized to receive an eight week supply of either a lower dose of XOS or placebo (no active substance). This will be determined randomly, in a process similar to flipping a coin. Blood samples will be taken at each visits, including an oral glucose tolerance test. Subjects will also be asked to collect and bring in stool samples at three different time points during the study.

Subjects will have a 50/50 chance of being assigned to the either study group. This is a double-blind study which means neither the study investigator nor the subject will know to which group he/she has been assigned. In case of an emergency, the study doctor can get this information.

Conditions

  • Pre-diabetic

Interventions

DIETARY_SUPPLEMENT

Sugar Pill

The placebo is identical in appearance to the XOS and contains 505mg maltodextrin

DIETARY_SUPPLEMENT

XOS 2.8

2.8g XOS is white or off-white crystalline substance and contains 500mg XOS 70P and 20mg maltodextrin

Sponsors & Collaborators

Principal Investigators

  • David Heber, MD, PhD · University of California, Los Angeles

  • Zhaoping Li, MD, PhD · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01944904 on ClinicalTrials.gov