NCT01861964

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 24, 2013

Completed
Last Updated

November 28, 2016

Status Verified

November 1, 2016

Enrollment Period

11 months

First QC Date

May 8, 2013

Last Update Submit

November 23, 2016

Conditions

BifidobacteriaHealthy Volunteers

Keywords

XOSXylooligosarcharidePrebiotic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Tolerance of XOS by healthy volunteers

    10 weeks

Study Arms (3)

Sugar Pill

PLACEBO COMPARATOR
Dietary Supplement: Placebo (Maltodextrin)

Xylooligosarcharide 2.8g

ACTIVE COMPARATOR

Xylooligosarcharide 2.8grams

Dietary Supplement: Xylooligosarcharide 2.8g

Xylooligosarcharide 1.4g

ACTIVE COMPARATOR
Dietary Supplement: Xylooligosarcharide 1.4g

Interventions

Placebo (Maltodextrin)DIETARY_SUPPLEMENT

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

Also known as: Maltodextrin
Sugar Pill
Xylooligosarcharide 1.4gDIETARY_SUPPLEMENT

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

Also known as: XOS 1.4g
Xylooligosarcharide 1.4g
Xylooligosarcharide 2.8gDIETARY_SUPPLEMENT

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

Also known as: XOS 2.8g
Xylooligosarcharide 2.8g

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCLA Center for Human Nutriiton

Los Angeles, California, 90095, United States

Location

UCLA Center for Human Nutrition, David Geffen School of Medicine

Los Angeles, California, 90095, United States

Location

Related Publications (1)

  • 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.

    PMID: 24513849RESULT

MeSH Terms

Interventions

maltodextrin

Study Officials

  • David Heber, MD, PhD

    UCLA Center for Human Nutrition

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2013

First Posted

May 24, 2013

Study Start

February 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

November 28, 2016

Record last verified: 2016-11

Locations

US(2)