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

This study has been completed.
Sponsor:
Information provided by:
Fugeia NV
ClinicalTrials.gov Identifier:
NCT01002651
First received: October 26, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Healthy
Dietary Supplement: wheat bran extract
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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

Further study details as provided by Fugeia NV:

Primary Outcome Measures:
  • Bifidobacteria content in feces [ Time Frame: day 19 or 20 of each intervention ] [ Designated as safety issue: No ]
  • butyric acid content in feces [ Time Frame: day 19 or 20 of each intervention ] [ Designated as safety issue: No ]
  • p-cresol content in urine [ Time Frame: day 19-21 of each intervention ] [ Designated as safety issue: No ]
  • stool frequency [ Time Frame: third week of each intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adverse events [ Time Frame: whole study ] [ Designated as safety issue: Yes ]
  • clinical blood parameters [ Time Frame: day 21 of each intervention ] [ Designated as safety issue: Yes ]

Enrollment: 66
Study Start Date: March 2009
Study Completion Date: October 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: arabinoxylan-oligosaccharides (AXOS)
Placebo Comparator: placebo Dietary Supplement: placebo
soft drink with natural flavor and coloring agent, without WBE, ingestion after breakfast and after dinner

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01002651

Locations
Belgium
Department of Gastrointestinal Research, Laboratory Digestion and Absorption
Leuven, Belgium, 3000
Sponsors and Collaborators
Fugeia NV
Investigators
Study Director: Willem Broekaert, Ph.D. Fugeia NV
  More Information

No publications provided

Responsible Party: Kristin Verbeke, Ph.D., Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01002651     History of Changes
Other Study ID Numbers: ML5282
Study First Received: October 26, 2009
Last Updated: October 26, 2009
Health Authority: Belgium: Institutional Review Board

Keywords provided by Fugeia NV:
gastrointestinal health
healthy subjects

ClinicalTrials.gov processed this record on September 16, 2014