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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01002651
• Other study ID #: ML5282
• Status: Completed
• Phase: N/A
• First received: October 26, 2009
• Last updated: October 26, 2009
• Start date: March 2009
• Est. completion date: October 2009

Study information

• Verified date: October 2009
• Source: Fugeia NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• wheat bran extract
soft drink comprising high WBE dose and natural flavor and coloring agent, ingestion after breakfast and after dinner
• placebo
soft drink with natural flavor and coloring agent, without WBE, ingestion after breakfast and after dinner

Locations

Country	Name	City	State
Belgium	Department of Gastrointestinal Research, Laboratory Digestion and Absorption	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Fugeia NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bifidobacteria content in feces		day 19 or 20 of each intervention	No
Primary	butyric acid content in feces		day 19 or 20 of each intervention	No
Primary	p-cresol content in urine		day 19-21 of each intervention	No
Primary	stool frequency		third week of each intervention	No
Secondary	adverse events		whole study	Yes
Secondary	clinical blood parameters		day 21 of each intervention	Yes