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

Fugeia

Status: Completed

Conditions: Healthy Subjects; Gastrointestinal Health

Treatments: Dietary Supplement: Wheat Bran Extract; Dietary Supplement: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01001949

ML5282 junior

Details and patient eligibility

About

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).

Enrollment: 29 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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29 participants in 2 patient groups, including a placebo group

Wheat Bran Extract

Experimental group

Treatment:

Dietary Supplement: Wheat Bran Extract

placebo

Placebo Comparator group

Treatment:

Dietary Supplement: placebo