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

NCT01944904 | Completed

• 1 other identifier: XOS2 053113
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

XOS; pre-diabetic; abnormal glucose levels

Outcome Measures

Primary Outcomes (1)

• The Effects of Xyloologosarcharide (XOS) on colonic flora in volunteers with abnormal glucose levels

  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.

  10 weeks

Secondary Outcomes (1)

• The Effects of Xyloologosarcharide (XOS) on glucose and insulin

  10 weeks

Other Outcomes (1)

• The effects of Xylooligosaccharide (XOS) on body weight and body composition

  10 weeks

Study Arms (2)

Sugar Pill

PLACEBO COMPARATOR

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

XOS 2.8

ACTIVE COMPARATOR

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

Interventions

Sugar Pill DIETARY_SUPPLEMENT

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

Sugar Pill

XOS 2.8 DIETARY_SUPPLEMENT

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

XOS 2.8

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20-70 years of age at screen
• BMI between 27 to 35
• Fasting glucose level \>100 mg/dL or \>200 mg/dL at 1 hour after ingesting of 75 grams of glucose
• 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

You may not qualify if:

• 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.
• Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
• Any subject who currently uses tobacco products.
• Any history of gastrointestinal disease except for appendectomy
• No antibiotics or laxatives use during the 2 months before the study.
• Any subject who is unable or unwilling to comply with the study protocol.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Center for Human Nutrition

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Yang J, Summanen PH, Henning SM, Hsu M, Lam H, Huang J, Tseng CH, Dowd SE, Finegold SM, Heber D, Li Z. Xylooligosaccharide supplementation alters gut bacteria in both healthy and prediabetic adults: a pilot study. Front Physiol. 2015 Aug 7;6:216. doi: 10.3389/fphys.2015.00216. eCollection 2015.

  PMID: 26300782 RESULT

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Sugars

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• David Heber, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Zhaoping Li, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: September 18, 2013
• Study Start: September 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 1, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)