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Completed

NCT Number: NCT01001949

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

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).

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Key information

Conditions

Gastrointestinal Health Healthy Subjects

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gastrointestinal Research, Laboratory Digestion and Absorption

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wheat Bran Extract

Dietary Supplement

soft drink comprising WBE and natural flavor and coloring agent, ingestion after breakfast and after dinner

Placebo

Dietary Supplement

soft drink with natural flavor and coloring agent, without WBE, ingestion after breakfast and dinner

Primary outcomes

  1. Bifidobacteria content in feces

    Time frame: day 19 or 20 of each intervention period

  2. butyric acid content in feces

    Time frame: day 19 or 20 of each intervention period

  3. stool frequency

    Time frame: third week of each intervention period

Secondary outcomes

  1. adverse events

    Time frame: whole study period

Sponsors and collaborators

Lead sponsor

Fugeia NV

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Oct 27, 2009
Registry last updated
Oct 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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