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Completed

NCT Number: NCT01002651

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

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.

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Key information

Conditions

Age range

18 year–90 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

  • 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.

Treatment and study plan

Wheat Bran Extract

Dietary Supplement

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

Other names: arabinoxylan-oligosaccharides (AXOS)

Placebo

Dietary Supplement

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

Primary outcomes

  1. Bifidobacteria content in feces

    Time frame: day 19 or 20 of each intervention

  2. butyric acid content in feces

    Time frame: day 19 or 20 of each intervention

  3. p-cresol content in urine

    Time frame: day 19-21 of each intervention

  4. stool frequency

    Time frame: third week of each intervention

Secondary outcomes

  1. adverse events

    Time frame: whole study

  2. clinical blood parameters

    Time frame: day 21 of each intervention

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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