In Vivo Evaluation of the Physiological Effects of Arabinoxylan-oligosaccharides (AXOS) in Healthy Subjects (Adults)

In Vivo Evaluation of the Physiological Effects of Arabinoxylan-oligosaccharides (AXOS) in Healthy Subjects: a Randomized, Placebo-controlled, Double-blind, Cross-over Study

The investigational study product used in this clinical trial is a soft drink containing an arabinoxylan-oligosaccharides (AXOS) preparation extracted from wheat bran (hereafter called Wheat Bran Extract, WBE).

The objective of this study is to analyze the effect of the intake of two WBE doses on various parameters of gastrointestinal health. Additionally, safety was analyzed using treatment emergent Adverse Events (AEs) and clinical blood parameters.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: wheat bran extract; Dietary supplement: placebo

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Department of Gastrointestinal Research, Laboratory Digestion and Absorption

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female 18-90 years of age, inclusive
• Regular eating habits
• Body Mass Index (BMI) between 18.5 and 30 kg/m2
• Consent to take in the study product according to the study protocol
• Subject is willing to maintain his or her habitual food and beverage intake throughout the study period (with the exception of omission of prebiotic and probiotic food products as indicated in the study protocol)
• For female volunteers of childbearing potential: not planning to become pregnant during the clinical trial and willing to commit to the use of a medically approved form of contraception

Exclusion Criteria:

• Low-calorie diet or other extreme dietary habits in the 6 weeks before the start of the clinical trial
• Recent use of antibiotics
• Abdominal surgery in the past
• Serious illness within 3 months of start of clinical trial
• Use of medication or dietary supplements known to influence GI tract within two weeks of start of clinical trial. Examples of such medication/dietary supplements are antispasmodics, anti diarrhea medication and/or probiotic medication
• Complete anesthetics within 1 month of the start of the clinical trial
• Chronic GI conditions such as inflammatory bowel disease (IBD), inflammatory bowel syndrome (IBS), chronic constipation, history of frequent diarrhea, clinically important lactose intolerance
• Allergy for wheat products
• Celiac disease
• For female volunteers: pregnant or lactating
• Alcohol abuse
• Smoking more than 5 cigarettes per day
• Subject has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the subject at undue risk.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Dietary supplement: placebo; soft drink with natural flavor and coloring agent, without WBE, ingestion after breakfast and after dinner
Experimental: Wheat Bran Extract (high dose)	Dietary supplement: wheat bran extract; soft drink comprising high WBE dose and natural flavor and coloring agent, ingestion after breakfast and after dinner; Other Names: arabinoxylan-oligosaccharides (AXOS)
Experimental: Wheat Bran Extract (low dose)	Dietary supplement: wheat bran extract; soft drink comprising high WBE dose and natural flavor and coloring agent, ingestion after breakfast and after dinner; Other Names: arabinoxylan-oligosaccharides (AXOS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bifidobacteria content in feces	day 19 or 20 of each intervention
butyric acid content in feces	day 19 or 20 of each intervention
p-cresol content in urine	day 19-21 of each intervention
stool frequency	third week of each intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
adverse events	whole study
clinical blood parameters	day 21 of each intervention

Collaborators and Investigators

• Sponsor: Fugeia NV
• Investigators: Study Director: Willem Broekaert, Ph.D., Fugeia NV

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: October 26, 2009
• First Submitted That Met QC Criteria: October 26, 2009
• First Posted (Estimate): October 27, 2009

Study Record Updates

• Last Update Posted (Estimate): October 27, 2009
• Last Update Submitted That Met QC Criteria: October 26, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: healthy subjects; gastrointestinal health
• Other Study ID Numbers: ML5282