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Investigation of the Ability of a Supplement to Increase Good Bacteria in the Human Intestine and Blood Sugar Levels (XOS2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01944904
First Posted: September 18, 2013
Last Update Posted: March 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zhaoping Li, University of California, Los Angeles
  Purpose

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.


Condition Intervention
Pre-diabetic Dietary Supplement: Sugar Pill Dietary Supplement: XOS 2.8

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Study of the Effect of Prebiotic Xylooligosaccharide (XOS) on Microbita and Blood Glucose

Resource links provided by NLM:


Further study details as provided by Zhaoping Li, University of California, Los Angeles:

Primary Outcome Measures:
  • The Effects of Xyloologosarcharide (XOS) on colonic flora in volunteers with abnormal glucose levels [ Time Frame: 10 weeks ]
    After 2 weeks of run-in, 20 healthy volunteers with fasting glucose level >100 mg/dL or >200 mg/dL at 1 hour after ingesting of 75 grams of glucose will be randomly assigned to take 2.8 grams/day or placebo for 8 weeks. The bifidobarteria counts will be assessed at screening, baseline and 8 weeks on supplementation of XOS and cessation of XOS.


Secondary Outcome Measures:
  • The Effects of Xyloologosarcharide (XOS) on glucose and insulin [ Time Frame: 10 weeks ]
    Glucose, insulin and triglyceride levels will be tested at time 0, 30 min, 60 min, and 120 min after 75 grams of glucose load at baseline and 8 weeks.


Other Outcome Measures:
  • The effects of Xylooligosaccharide (XOS) on body weight and body composition [ Time Frame: 10 weeks ]
    Body weight and body composition will be measured at baseline and week 8.


Enrollment: 18
Study Start Date: September 2013
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar Pill
Subjects will be asked to take the dietary supplement daily for 8 weeks. Blood samples will be taken at screen, baseline and week 8. An oral glucose tolerance test will be taken at baseline and week 8. Additionally subjects will be asked to collect their stool samples at Baseline, week 4, and 8. Subjects will also undergo a test to determine their body composition at baseline and week 8. Subjects will be asked to keep a diary of their bowel habits and any symptoms that might be related to the supplement. Subjects will be asked to recall the foods that they have eaten in the past 24 hours and to avoid any foods that contain XOS and probiotic bacteria during the study.
Dietary Supplement: Sugar Pill
The placebo is identical in appearance to the XOS and contains 505mg maltodextrin
Active Comparator: XOS 2.8
Subjects will be asked to take the dietary supplement daily for 8 weeks. Blood samples will be taken at screen, baseline and week 8. An oral glucose tolerance test will be taken at baseline and week 8. Additionally subjects will be asked to collect their stool samples at Baseline, week 4, and 8. Subjects will also undergo a test to determine their body composition at baseline and week 8. Subjects will be asked to keep a diary of their bowel habits and any symptoms that might be related to the supplement. Subjects will be asked to recall the foods that they have eaten in the past 24 hours and to avoid any foods that contain XOS and probiotic bacteria during the study.
Dietary Supplement: XOS 2.8
2.8g XOS is white or off-white crystalline substance and contains 500mg XOS 70P and 20mg maltodextrin

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 20-70 years of age at screen
  2. BMI between 27 to 35
  3. Fasting glucose level >100 mg/dL or >200 mg/dL at 1 hour after ingesting of 75 grams of glucose
  4. Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. A subject will be excluded for any condition that might compromise the ability to give truly informed consent

Exclusion Criteria:

  1. Any subject with a history of diabetes mellitus on medications, or other serious medical condition, such as chronic hepatic or renal disease, bleeding disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as systolic BP>160mmHg, diastolic BP>95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history or routine physical examination.
  2. Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
  3. Any subject who currently uses tobacco products.
  4. Any history of gastrointestinal disease except for appendectomy
  5. No antibiotics or laxatives use during the 2 months before the study.
  6. Any subject who is unable or unwilling to comply with the study protocol.
  Contacts and Locations
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): NCT01944904


Locations
United States, California
UCLA Center for Human Nutrition
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: David Heber, MD, PhD UCLA Department of Medicine
Principal Investigator: Zhaoping Li, MD, PhD UCLA Department of Medicine
  More Information

Publications:
Responsible Party: Zhaoping Li, Professor of Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01944904     History of Changes
Other Study ID Numbers: XOS2 053113
First Submitted: September 4, 2013
First Posted: September 18, 2013
Last Update Posted: March 1, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD with other researchers.

Keywords provided by Zhaoping Li, University of California, Los Angeles:
XOS
pre-diabetic
abnormal glucose levels

Additional relevant MeSH terms:
Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases