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OpenTrials
Completed

NCT Number: NCT01861964

Effects of Xylooligosarcharide on Composition of the Human Colonic Microflora

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.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

UCLA Center for Human Nutriiton, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo (Maltodextrin)

Dietary Supplement

Maltodextrin 505mg/capsule 8 capsules/day (4 with breakfast and 4 with dinner meal)

Other names: Maltodextrin

Xylooligosarcharide 1.4g

Dietary Supplement

8 capsules (512 mg/capsule) 4 with breakfast and 4 with dinner meal

Other names: XOS 1.4g

Xylooligosarcharide 2.8g

Dietary Supplement

8 capsules (520 mg/capsule) to be taken in the morning and in the evening

Other names: XOS 2.8g

Primary outcomes

  1. 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

  1. Tolerance of XOS by healthy volunteers

    Time frame: 10 weeks

    The tolerance of XOS was assessed by questionnaires, adverse event logs with comparison with placebo control group

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Acronym: XOS

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 24, 2013
Registry last updated
Nov 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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