Effect of Fiber Composite-enriched Breads on Glycemic Responses

Sponsor

Glycemic Index Laboratories, Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT03224806

Collaborator

University of Guelph (Other), Guelph Research and Development Centre, Agriculture and Agri-Food Canada (Other)

Enrollment

Location

Arms

Actual Duration (Days)

30.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glycemic Response	Other: Wholegrain bread Other: White bread Other: 15% fiber-rich bread Other: 30% fiber-rich bread	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Effect of Fiber Composite-enriched Breads on Glycemic Responses

Actual Study Start Date :

Jun 3, 2014

Actual Primary Completion Date :

Jun 13, 2014

Actual Study Completion Date :

Jun 13, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: Wholegrain bread	Other: Wholegrain bread 156.8g wholegrain bread
Other: White bread	Other: White bread 122.6g white bread
Other: 15% fiber-rich bread	Other: 15% fiber-rich bread 139.2g bread made with 15% added wheat bran
Other: 30% fiber-rich bread	Other: 30% fiber-rich bread 166.5g bread made with 30% added wheat bran

Outcome Measures

Primary Outcome Measures

Glucose AUC [2 hours]
Incremental area under the glucose response curve ignoring area below fasting glucose

Secondary Outcome Measures

Satiety AUC [2 hours]
Incremental area under the satiety response curve
Hydrolysis index [2 hours]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Glycemic Index Laboratories, Inc.	Toronto	Ontario	Canada	M5C 2X3

Sponsors and Collaborators

Glycemic Index Laboratories, Inc
University of Guelph
Guelph Research and Development Centre, Agriculture and Agri-Food Canada

Investigators

Principal Investigator: Thomas MS Wolever, MD, PhD, GI Labs

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Glycemic Index Laboratories, Inc

ClinicalTrials.gov Identifier:

NCT03224806

Other Study ID Numbers:

GIL-1426

First Posted:

Jul 21, 2017

Last Update Posted:

Jul 21, 2017

Last Verified:

Jul 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 21, 2017