Effects of Xylooligosarcharide on Composition of the Human Colonic Microflora
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 30
- Locations
- 4
- Primary Endpoint
- The Effects of Xyloologosarcharide (XOS) on colonic bifidobacteria counts in healthy volunteers.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 20-50 years of age at screen.
- •In generally good health
- •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
- •Any history of gastrointestinal disease except for appendectomy
- •No antibiotic, pre- or probiotic or laxative use during the 2 months before the study.
- •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.
- •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 subject who is pregnant or lactating, or becomes pregnant during the study.
- •Any subject who is unable or unwilling to comply with the study protocol.
Outcomes
Primary Outcomes
The Effects of Xyloologosarcharide (XOS) on colonic bifidobacteria counts in healthy volunteers.
Time Frame: 10 weeks
After a 2 weeks of run-in, 30 healthy volunteers were randomly assigned to take 1.4 grams/day of XOS, or 2.8 grams/day or placebo for 8 weeks. The bifidobarteria counts was assessed at screening, baseline, 4, 8 weeks on supplementation of XOS and after 2 week cessation of XOS.
Secondary Outcomes
- Tolerance of XOS by healthy volunteers(10 weeks)