Clinical trial NCT01002651: In Vivo Evaluation of the Physiological Effects of Arabinoxylan-oligosaccharides (AXOS) in Healthy Subjects (Adults)
Official title: In Vivo Evaluation of the Physiological Effects of Arabinoxylan-oligosaccharides (AXOS) in Healthy Subjects: a Randomized, Placebo-controlled, Double-blind, Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: gastrointestinal health
healthy subjects
Lead sponsor: Fugeia NV
Sponsor class: INDUSTRY
First posted: 2009-10-27
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Bifidobacteria content in feces
timeFrame: day 19 or 20 of each intervention
measure: butyric acid content in feces
timeFrame: day 19 or 20 of each intervention
measure: p-cresol content in urine
timeFrame: day 19-21 of each intervention
measure: stool frequency
timeFrame: third week of each intervention
Secondary outcomes:
measure: adverse events
timeFrame: whole study
measure: clinical blood parameters
timeFrame: day 21 of each intervention
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Department of Gastrointestinal Research, Laboratory Digestion and Absorption
Study officials:
affiliation: Fugeia NV
name: Willem Broekaert, Ph.D.
role: STUDY_DIRECTOR
References: