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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: wheat bran extract
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastrointestinal health, healthy subjects