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Trial record 10 of 98 for:    grams | maltodextrin

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

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.

Condition or disease Intervention/treatment Phase
Bifidobacteria Healthy Volunteers Dietary Supplement: Placebo (Maltodextrin) Dietary Supplement: Xylooligosarcharide 1.4g Dietary Supplement: Xylooligosarcharide 2.8g Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Official Title: Effects of Xylooligosarcharide on Composition of the Human Colonic Microflora
Study Start Date : February 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

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 Name: 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 Name: 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 Name: XOS 1.4g




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861964


Locations
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United States, California
UCLA Center for Human Nutriiton
Los Angeles, California, United States, 90095
UCLA Center for Human Nutrition, David Geffen School of Medicine
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: David Heber, MD, PhD UCLA Center for Human Nutrition

Publications of Results:
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Responsible Party: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01861964     History of Changes
Other Study ID Numbers: LBIXOS001
First Posted: May 24, 2013    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016
Keywords provided by University of California, Los Angeles:
XOS
Xylooligosarcharide
Prebiotic