Effects of Xylooligosarcharide on Composition of the Human Colonic Microflora

Phase 2

Completed

• Conditions: Bifidobacteria; Healthy Volunteers
• Interventions: Dietary Supplement: Placebo (Maltodextrin); Dietary Supplement: Xylooligosarcharide 2.8g; Dietary Supplement: Xylooligosarcharide 1.4g

• Registration Number: NCT01861964
• Lead Sponsor: University of California, Los Angeles

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Study First Submitted: 2013-05-08
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-24
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-23
• Last Update Posted: 2016-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sugar Pill	Placebo (Maltodextrin)	-
Xylooligosarcharide 2.8g	Xylooligosarcharide 2.8g	Xylooligosarcharide 2.8grams
Xylooligosarcharide 1.4g	Xylooligosarcharide 1.4g	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

UCLA Center for Human Nutriiton; 🇺🇸 Los Angeles, California, United States

UCLA Center for Human Nutrition, David Geffen School of Medicine; 🇺🇸 Los Angeles, California, United States