Effects of Xylooligosarcharide on Composition of the Human Colonic Microflora

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Xylooligosarcharide on Composition of the Human Colonic Microflora

Conditions
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Bifidobacteria, Healthy Volunteers

Intervention / Treatment
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* Dietary Supplement: Placebo (Maltodextrin)
* Dietary Supplement: Xylooligosarcharide 1.4g
* Dietary Supplement: Xylooligosarcharide 2.8g


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sugar Pill<br> | Dietary Supplement: Placebo (Maltodextrin)<br>* Maltodextrin 505mg/capsule 8 capsules/day (4 with breakfast and 4 with dinner meal)<br>* Other names: Maltodextrin;|
| Active Comparator: Xylooligosarcharide 2.8g<br>Xylooligosarcharide 2.8grams | Dietary Supplement: Xylooligosarcharide 2.8g<br>* 8 capsules (520 mg/capsule) to be taken in the morning and in the evening<br>* Other names: XOS 2.8g;|
| Active Comparator: Xylooligosarcharide 1.4g<br> | Dietary Supplement: Xylooligosarcharide 1.4g<br>* 8 capsules (512 mg/capsule) 4 with breakfast and 4 with dinner meal<br>* Other names: XOS 1.4g;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Effects of Xyloologosarcharide (XOS) on colonic bifidobacteria counts in healthy volunteers. | 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. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance of XOS by healthy volunteers | The tolerance of XOS was assessed by questionnaires, adverse event logs with comparison with placebo control group | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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XOS, Xylooligosarcharide, Prebiotic