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

Completed · Not applicable · Has a placebo group

Conditions studied: Pre-diabetic

In brief

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.

Key facts

Study ID

NCT01944904

Run by

University of California, Los Angeles

People needed

18

Starts

2013-09-01

Expected to finish

2014-08-01

Last updated by the study team

2017-03-01

Who can join

Age: 20 and older, up to 70. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• UCLA Center for Human Nutrition — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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