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Randomized double blind placebo-controlled intervention study to investigate effects of VITACEL extrinsic wheat fibers for maintenance of normal defecation by increasing fecal bulk in healthy subjects

Randomized double blind placebo-controlled intervention study to investigate effects of VITACEL extrinsic wheat fibers for maintenance of normal defecation by increasing fecal bulk in healthy subjects

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
DRKS
Registry ID
DRKS00026262
Enrollment
64
Registered
2021-09-27
Start date
2021-10-06
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Regular digestion

Interventions

Group 1: Wheat fiber intervention (dietary fiber concentrate) Group 2: Placebo-control with maltodextrin

Sponsors

J. Rettenmaier & Söhne GmbH + Co KG
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Good physical and mental health, stool frequency between 4 and 7 movements per week, BMI between 19 and 32 kg/m2, non-smoker, written consent to participate in the study

Exclusion criteria

Exclusion criteria: Mediacal disorders interfering with the study, subjects under prescription for medication or taking dietary supplements possibly interfering with this study, prior abdominal surgery, intake of antibiotics in the last 3 months prior to screening, use of pre- and probiotic supplements, subjects consuming food or drinks claimed as 'probiotic' or 'prebiotic', food or dinks claimed "rich in fiber', more than 3 portions of fruits and vegetables (sum) per day, vegans and vegetarians, regular laxative use, regular stool consistency of diarrheal subtype

Design outcomes

Primary

MeasureTime frame
Fecal bulk; collection with a fecontainer and weighing with a digital scale over three weeks

Secondary

MeasureTime frame
Stool frequency; app-based documentation of the stool frequency

Countries

Germany

Contacts

Public ContactChristiane Schön

BioTeSys GmbH

c.schoen@biotesys.de+4971131057145

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026