Bifidobacteria, Healthy Volunteers
Conditions
Keywords
XOS, Xylooligosarcharide, Prebiotic
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.
Interventions
DIETARY_SUPPLEMENTPlacebo (Maltodextrin)
Maltodextrin 505mg/capsule 8 capsules/day (4 with breakfast and 4 with dinner meal)
DIETARY_SUPPLEMENTXylooligosarcharide 1.4g
8 capsules (512 mg/capsule) 4 with breakfast and 4 with dinner meal
DIETARY_SUPPLEMENTXylooligosarcharide 2.8g
8 capsules (520 mg/capsule) to be taken in the morning and in the evening
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Effects of Xyloologosarcharide (XOS) on colonic bifidobacteria counts in healthy volunteers. | 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
| Measure | Time frame | Description |
|---|---|---|
| Tolerance of XOS by healthy volunteers | 10 weeks | The tolerance of XOS was assessed by questionnaires, adverse event logs with comparison with placebo control group |
Countries
United States
Outcome results
None listed