The Impact of Modified Wheat Bran on Carbohydrate Ferment... | NCT02796989

Studies
The Impact of Modified Wheat Bran on Carbohydrate Fermentation in the Colon in Healthy and Obese Subjects

NCT02796989

Sponsor

KU Leuven

Status

Completed

Last Update Posted

Feb 26, 2021Actual

Enrollment

50Actual

Phase

Phase 1Phase 2

Conditions

Healthy
Obese

Interventions

Wheat bran
Placebo

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

Feb 2021

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

Mar 2016

Primary Completion Date

Dec 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

May 27, 2016

First Submission Date that Met QC Criteria

Jun 10, 2016

First Posted Date

Jun 13, 2016Estimated

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

Feb 24, 2021

Last Update Posted Date

Feb 26, 2021Actual

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 modified wheat bran on colon health and systemic health will be evaluated in a long-term intervention study in healthy and obese subjects.

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

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy - Wheat Bran	Active Comparator	Wheat bran 20 g each day	Dietary Supplement: Wheat bran
Healthy - Placebo	Placebo Comparator	Placebo 20 g each day	Dietary Supplement: Placebo
Obese - Wheat bran	Active Comparator	Wheat bran 20 g each day	Dietary Supplement: Wheat bran
Obese - Placebo	Placebo Comparator	Placebo 20 g each day	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Wheat bran	Dietary Supplement	20 g each day	Healthy - Wheat Bran Obese - Wheat bran

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incremental plasma short-chain fatty acid concentrations will be measured using GC-FID after an intervention with wheat bran/placebo		1 month

Secondary Outcomes

Measure	Description	Time Frame
Changes in glucose levels (mg/dL)		1 month
Changes in insulin levels (pmol/L)		1 month
Changes in cholesterol levels (mg/dL)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged between 18 and 65 years old
BMI between 18 and 25 kg/m² OR higher than 30 kg/m²
Regular diet
Not dieting

Exclusion Criteria:

Use of antibiotics in the month preceding the study
Diabetes Type 1 or 2
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

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

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

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