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

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ClinicalTrials.gov Identifier: NCT01861964
Recruitment Status : Completed
First Posted : May 24, 2013
Last Update Posted : November 28, 2016
Sponsor:
Information provided by (Responsible Party):
University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE May 8, 2013
First Posted Date  ICMJE May 24, 2013
Last Update Posted Date November 28, 2016
Study Start Date  ICMJE February 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01861964 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2013)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Xylooligosarcharide on Composition of the Human Colonic Microflora
Official Title  ICMJE Effects of Xylooligosarcharide on Composition of the Human Colonic Microflora
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE
  • Bifidobacteria
  • Healthy Volunteers
Intervention  ICMJE
  • Dietary Supplement: Placebo (Maltodextrin)
    Maltodextrin 505mg/capsule 8 capsules/day (4 with breakfast and 4 with dinner meal)
    Other Name: Maltodextrin
  • Dietary Supplement: Xylooligosarcharide 1.4g
    8 capsules (512 mg/capsule) 4 with breakfast and 4 with dinner meal
    Other Name: XOS 1.4g
  • Dietary Supplement: Xylooligosarcharide 2.8g
    8 capsules (520 mg/capsule) to be taken in the morning and in the evening
    Other Name: XOS 2.8g
Study Arms  ICMJE
  • Placebo Comparator: Sugar Pill
    Intervention: Dietary Supplement: Placebo (Maltodextrin)
  • Active Comparator: Xylooligosarcharide 2.8g
    Xylooligosarcharide 2.8grams
    Intervention: Dietary Supplement: Xylooligosarcharide 2.8g
  • Active Comparator: Xylooligosarcharide 1.4g
    Intervention: Dietary Supplement: Xylooligosarcharide 1.4g
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2013)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01861964
Other Study ID Numbers  ICMJE LBIXOS001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Heber, MD, PhD UCLA Center for Human Nutrition
PRS Account University of California, Los Angeles
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP