Clinical trial NCT01861964: Effects of Xylooligosarcharide on Composition of the Human Colonic Microflora
Official title: Effects of Xylooligosarcharide on Composition of the Human Colonic Microflora
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Bifidobacteria
Healthy Volunteers
Keywords: XOS
Xylooligosarcharide
Prebiotic
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2013-05-24
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Human and animal studies demonstrate that xylooligosaccharides (XOS) are a highly efficacious prebiotic ingredient that delivers benefits at a minimum level of 1.4 g/day (d), which is much lower than levels required by fructooligosaccharides (FOS, 5 g/d) or galactooligosaccharides (GOS, 8 g/d). XOS promotes gastrointestinal regularity and relieves diarrhea and constipation at 0.7 g/d and 1.4 g/d, respectively. Xylooligosaccharides may also reduce blood cholesterol and may improve glycemic control, although more data from clinical trials are needed to confirm preliminary findings.


Eligibility criteria: Inclusion Criteria:

1. Age 20-50 years of age at screen.
2. In generally good health
3. 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 history of gastrointestinal disease except for appendectomy
2. No antibiotic, pre- or probiotic or laxative use during the 2 months before the study.
3. Any subject with a history of diabetes mellitus, 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.
4. Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
5. Any subject who currently uses tobacco products.
6. Any subject who is pregnant or lactating, or becomes pregnant during the study.
7. Any subject who is unable or unwilling to comply with the study protocol.

Primary outcomes:
measure: The Effects of Xyloologosarcharide (XOS) on colonic bifidobacteria counts in healthy volunteers.
timeFrame: 10 weeks
Secondary outcomes:
measure: Tolerance of XOS by healthy volunteers
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Center for Human Nutriiton
state: California
city: Los Angeles
country: United States
facility: UCLA Center for Human Nutrition, David Geffen School of Medicine
state: California
Study officials:
affiliation: UCLA Center for Human Nutrition
name: David Heber, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Finegold SM, Li Z, Summanen PH, Downes J, Thames G, Corbett K, Dowd S, Krak M, Heber D. Xylooligosaccharide increases bifidobacteria but not lactobacilli in human gut microbiota. Food Funct. 2014 Mar;5(3):436-45. doi: 10.1039/c3fo60348b.