Effect of Different Bran-based Dietary Platforms on the C... | NCT02422537

Studies
Effect of Different Bran-based Dietary Platforms on the Colon Metabolism in Healthy Volunteers

NCT02422537

Sponsor

KU Leuven

Status

Completed

Last Update Posted

Jan 31, 2017Estimated

Enrollment

10Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Unmodified wheat bran
Wheat bran with reduced particle size
Destarched pericarp-enriched wheat bran
No wheat bran fraction

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Jul 2015Actual

Completion Date

Jan 2017Actual

First Submitted Date

Apr 10, 2015

First Submission Date that Met QC Criteria

Apr 16, 2015

First Posted Date

Apr 21, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2017

Last Update Posted Date

Jan 31, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

During this project the effect of 3 different bran-based dietary platforms on the fermentation on a readily fermentable substrate will be investigated using stable isotope techniques.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Unmodified wheat bran	Active Comparator	One single dose om 20 g	Dietary Supplement: Unmodified wheat bran
Wheat bran with reduced particle size	Active Comparator	One single dose of 20 g	Dietary Supplement: Wheat bran with reduced particle size
Destarched pericarp-enriched wheat bran	Active Comparator	One single dose of 20 g	Dietary Supplement: Destarched pericarp-enriched wheat bran
No bran-based dietary platform	Other	No wheat bran fractions is administered	Dietary Supplement: No wheat bran fraction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Unmodified wheat bran	Dietary Supplement		Unmodified wheat bran
Wheat bran with reduced particle size

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quantification of acetate, propionate and butyrate production in the colon after consumption of each bran-based dietary platform		2 years

Secondary Outcomes

Measure	Description	Time Frame
Estimation of the site of fermentation of a readily fermentable carbohydrate in the presence of different bran-based dietary platforms		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy
Aged between 18 and 65 years
BMI between 18 and 27 kg/m²
Stable eating pattern (3 meals/day on at least 5 days/week)

Exclusion Criteria:

Use of antibiotics in the month preceding the study
Abdominal surgery (except from appendectomy)
Use of medication that affects the gastrointestinal tract during the last 2 weeks prior to the study including spasmolytics, anti-diarrhoea medication, anti-constipation medication
Use of pre- or probiotic supplements in the month preceding the study
Chronic gastrointestinal diseases, such as inflammatory bowel disease (Crohn's disease, ulcerative colitis), irritable bowel disease…
Pregnancy or lactation
Blood donation in the last 3 months
Abnormal Hb-level (Standard range between 14 and 18 g/dL for men and between 12 and 16 g/dL for women)
Participation in clinical studies involving radiation exposure in the past year

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
KU Leuven/ UZ Leuven		Leuven	Vlaams-Brabant	3000	Belgium

Intervention Browse Module

MeSH Terms

ID	Term
D004043	Dietary Fiber

Ancestor Terms

ID	Term
D004040	Dietary Carbohydrates
D002241	Carbohydrates
D005502	Food
D000066888	Diet, Food, and Nutrition

Browse Leaves

Not provided

Browse Branches

Not provided