Effect of Fiber Composite-enriched Breads on Glycemic Res... | NCT03224806

Studies
Effect of Fiber Composite-enriched Breads on Glycemic Responses

NCT03224806

Sponsor

Glycemic Index Laboratories, Inc

Status

Completed

Last Update Posted

Jul 21, 2017Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Glycemic Response

Interventions

Wholegrain bread
White bread
15% fiber-rich bread
30% fiber-rich bread

Countries

Canada

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

Jul 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

Jun 3, 2014Actual

Primary Completion Date

Jun 13, 2014Actual

Completion Date

Jun 13, 2014Actual

First Submitted Date

Jul 19, 2017

First Submission Date that Met QC Criteria

Jul 19, 2017

First Posted Date

Jul 21, 2017Actual

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

Jul 19, 2017

Last Update Posted Date

Jul 21, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Glycemic Index Laboratories, IncINDUSTRY

Collaborators

Name	Class
University of Guelph	OTHER
Guelph Research and Development Centre, Agriculture and Agri-Food Canada	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Health organizations recommend fiber-rich and whole-grain foods for healthy diets due to their physiological beneficial effects on human health. But, little information is available between these 2 food categories, i.e. fiber added to foods versus fiber naturally present in foods. The present study investigated the effect of enriching white wheat flour with wheat bran at 2 levels (15 and 30%) to produce 15% fiber-rich bread (15FRB) and 30% fiber-rich bread (30FRB) and compared them with white bread (WB) and whole-grain bread (WGB) in terms of bread quality, palatability, satiety, and glycemic response. Ten healthy subjects were studied on 4 separate days with each subject testing all 4 types of bread. On each test day subjects came to the test center after an overnight fast. After 2 fasting finger-prick blood samples, they ate a portion of one of the breads containing 50g available carbohydrate and had further blood samples at intervals over 2 hours. They also rated their feelings of satiety fasting and at intervals over 2 hours.

Detailed Description

Health organizations recommend fiber-rich and whole-grain foods for healthy diets due to their physiological beneficial effects on human health. But, little information is available between these 2 food categories, i.e. fiber added to foods versus fiber naturally present in foods. The present study investigated the effect of enriching white wheat flour with wheat bran at 2 levels (15 and 30%) to produce 15% fiber-rich bread (15FRB) and 30% fiber-rich bread (30FRB) and compared them with white bread (WB) and whole-grain bread (WGB) in terms of bread quality, palatability, satiety, and glycemic response. Ten healthy subjects were studied on 4 separate days with each subject testing all 4 types of bread. On each test day subjects came to the test center after an overnight fast. After 2 fasting finger-prick blood samples 5 minutes apart, they ate a portion of one of the breads containing 50g available carbohydrate and had further blood samples at 15, 30, 45, 60,90 and 120 min after starting to eat. After each blood sample also rated their feelings of satiety on a 7-point scale from extremely hungry to extremely full.

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	Intervention Names
Wholegrain bread	Other	Other: Wholegrain bread
White bread	Other	Other: White bread
15% fiber-rich bread	Other	Other: 15% fiber-rich bread
30% fiber-rich bread	Other	Other: 30% fiber-rich bread

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Wholegrain bread	Other	156.8g wholegrain bread	Wholegrain bread
White bread

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glucose AUC	Incremental area under the glucose response curve ignoring area below fasting glucose	2 hours

Secondary Outcomes

Measure	Description	Time Frame
Satiety AUC	Incremental area under the satiety response curve	2 hours
Hydrolysis index	Incremental area under the hydrolysis curve (amount of glucose released during in-vitro digestion of the breads) expressed as a percentage of that for white bread.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Good health

Exclusion Criteria:

Known history of AIDS, hepatitis, diabetes or a heart condition
Use of drugs which would increase risk to the subject or affect the results in the opinion of the medical director
Any condition which would increase risk to the subject or affect the results in the opinion of the medical director
Individuals who cannot or will not comply with experimental procedures or do not follow safety guidelines.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas MS Wolever, MD, PhD	GI Labs	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Glycemic Index Laboratories, Inc.		Toronto	Ontario	M5C 2X3	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided