Effects of Xylooligosarcharide on Composition of the Human Colonic Microflora

Healthy Volunteers Clinical Trial

— XOS  

Official title:

Effects of Xylooligosarcharide on Composition of the Human Colonic Microflora

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01861964
• Other study ID #: LBIXOS001
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 8, 2013
• Last updated: November 23, 2016
• Start date: February 2012
• Est. completion date: January 2013

Study information

• Verified date: November 2016
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Bifidobacteria
• Healthy Volunteers

Intervention

Dietary Supplement:
• Placebo (Maltodextrin)
Maltodextrin 505mg/capsule 8 capsules/day (4 with breakfast and 4 with dinner meal)
• Xylooligosarcharide 1.4g
8 capsules (512 mg/capsule) 4 with breakfast and 4 with dinner meal
• Xylooligosarcharide 2.8g
8 capsules (520 mg/capsule) to be taken in the morning and in the evening

Locations

Country	Name	City	State
United States	UCLA Center for Human Nutriiton	Los Angeles	California
United States	UCLA Center for Human Nutrition, David Geffen School of Medicine	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes