NCT01002651

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
Last Updated

October 27, 2009

Status Verified

October 1, 2009

Enrollment Period

3 months

First QC Date

October 26, 2009

Last Update Submit

October 26, 2009

Conditions

Healthy

Keywords

gastrointestinal healthhealthy subjects

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • adverse events

    whole study

  • clinical blood parameters

    day 21 of each intervention

Study Arms (3)

Wheat Bran Extract (high dose)

EXPERIMENTAL
Dietary Supplement: wheat bran extract

Wheat Bran Extract (low dose)

EXPERIMENTAL
Dietary Supplement: wheat bran extract

placebo

PLACEBO COMPARATOR
Dietary Supplement: placebo

Interventions

wheat bran extractDIETARY_SUPPLEMENT

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

Also known as: arabinoxylan-oligosaccharides (AXOS)
Wheat Bran Extract (high dose)Wheat Bran Extract (low dose)
placeboDIETARY_SUPPLEMENT

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

placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastrointestinal Research, Laboratory Digestion and Absorption

Leuven, 3000, Belgium

Location

MeSH Terms

Interventions

Dietary Fiber

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Willem Broekaert, Ph.D.

    Fugeia NV

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 26, 2009

First Posted

October 27, 2009

Study Start

March 1, 2009

Primary Completion

June 1, 2009

Study Completion

October 1, 2009

Last Updated

October 27, 2009

Record last verified: 2009-10

Locations

BE(1)