Gastrointestinal Health, Healthy Subjects
Conditions
Brief summary
The investigational product used in this study is a soft drink containing an arabinoxylan-oligosaccharide (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 WBE on various parameters of gastrointestinal health in children (8-12 yrs). Additionally, safety was analyzed using treatment emergent Adverse Events (AEs).
Interventions
DIETARY_SUPPLEMENTWheat Bran Extract
soft drink comprising WBE and natural flavor and coloring agent, ingestion after breakfast and after dinner
DIETARY_SUPPLEMENTplacebo
soft drink with natural flavor and coloring agent, without WBE, ingestion after breakfast and dinner
Sponsors
Fugeia NV
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* regular eating habits * consent to take in the study product according to the study protocol * consent of parents for follow-up of the protocol * subject is willing to maintain his/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)
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 * use of medication or dietary supplements known to influence gastrointestinal tract within two weeks of start of clinical trial. Examples of such medication/dietary supplements are antispasmodics, anti-diarrhea medication and/or probiotic medication * serious illness within 3 months of start of clinical trial * chronic gastrointestinal conditions such as inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), chronic constipation, history of frequent diarrhea, clinically important lactose intolerance * complete anesthetics within 3 month of the start of the clinical trial * allergy for wheat products * celiac disease * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bifidobacteria content in feces | day 19 or 20 of each intervention period |
| butyric acid content in feces | day 19 or 20 of each intervention period |
| stool frequency | third week of each intervention period |
Secondary
| Measure | Time frame |
|---|---|
| adverse events | whole study period |
Countries
Belgium
Outcome results
None listed