Effects of Xylooligosarcharide on Composition of the Human Colonic Microflora (XOS)

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 Overview

• Status: Completed
• Conditions: Healthy Volunteers; Bifidobacteria
• Intervention / Treatment: Dietary supplement: Placebo (Maltodextrin); Dietary supplement: Xylooligosarcharide 2.8g; Dietary supplement: Xylooligosarcharide 1.4g

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Center for Human Nutriiton
    • Los Angeles, California, United States, 90095
      • UCLA Center for Human Nutrition, David Geffen School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: David Heber, MD, PhD, UCLA Center for Human Nutrition

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: May 8, 2013
• First Submitted That Met QC Criteria: May 21, 2013
• First Posted (Estimate): May 24, 2013

Study Record Updates

• Last Update Posted (Estimate): November 28, 2016
• Last Update Submitted That Met QC Criteria: November 23, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Prebiotic; XOS; Xylooligosarcharide
• Other Study ID Numbers: LBIXOS001