Trials Sponsors Conditions Drugs Pricing

Conditions

Gastrointestinal Disorder, Functional

Outcome Measures

Primary Outcomes (1)

Whole gut transit time
Whole gut transit time is the time required for the passage of 80% of radio-opaque markers (ROM) which are detected by x-ray in the fecal samples collected over the next 5 days after swallowing the ROM.
4 weeks

Secondary Outcomes (15)

Whole gut transit time
2 weeks
Stool frequency
2 weeks and 4 weeks
Fecal output
2 weeks and 4 weeks
Percent fecal moisture
2 weeks and 4 weeks
Bristol Stool Score
2 weeks and 4 weeks
+10 more secondary outcomes

Study Arms (2)

Oat bran (Oatwell 28)

ACTIVE COMPARATOR

A beverage containing 11 gram (3 gram of oat beta-glucan) of Oat bran (Oatwell 28) will be consumed before breakfast

Other: Oat bran (Oatwell 28)

Maltodextrin

PLACEBO COMPARATOR

A beverage containing 11 gram of maltodextrin will be consumed before breakfast.

Other: Maltodextrin

Interventions

Oat bran (Oatwell 28)Other

11 g oat bran containing 3.1 gram oat beta-glucan

Also known as: Oat bran oat beta-glucan

Oat bran (Oatwell 28)

MaltodextrinOther

11 g of Maltodextrin

Maltodextrin

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy male or female between the ages of 18-60 years
Subject has a body mass index of ≥18.5 and ≤30 kg/m2 at screening visit.

Sponsors & Collaborators

dsm-firmenich Switzerland AG
Industrylead

Related Publications (3)

Grabitske HA, Slavin JL. Low-digestible carbohydrates in practice. J Am Diet Assoc. 2008 Oct;108(10):1677-81. doi: 10.1016/j.jada.2008.07.010.
PMID: 18926133BACKGROUND
Stewart ML, Nikhanj SD, Timm DA, Thomas W, Slavin JL. Evaluation of the effect of four fibers on laxation, gastrointestinal tolerance and serum markers in healthy humans. Ann Nutr Metab. 2010;56(2):91-8. doi: 10.1159/000275962. Epub 2010 Jan 19.
PMID: 20090313BACKGROUND
Chen HL, Haack VS, Janecky CW, Vollendorf NW, Marlett JA. Mechanisms by which wheat bran and oat bran increase stool weight in humans. Am J Clin Nutr. 1998 Sep;68(3):711-9. doi: 10.1093/ajcn/68.3.711.

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

Joanne Slavin, PhD
University of Minnesota
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: BASIC SCIENCE
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 21, 2016

First Posted

January 9, 2017

Study Start

June 2018

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Stopped

Effect of Oat Bran on Bowel Function and Appetite

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (15)

Study Arms (2)

Oat bran (Oatwell 28)

Maltodextrin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (15)

Study Arms (2)

Oat bran (Oatwell 28)

Maltodextrin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record