- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03224806
Effect of Fiber Composite-enriched Breads on Glycemic Responses
July 19, 2017 updated by: Glycemic Index Laboratories, Inc
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5C 2X3
- Glycemic Index Laboratories, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Wholegrain bread
|
156.8g wholegrain bread
|
Other: White bread
|
122.6g white bread
|
Other: 15% fiber-rich bread
|
139.2g bread made with 15% added wheat bran
|
Other: 30% fiber-rich bread
|
166.5g bread made with 30% added wheat bran
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose AUC
Time Frame: 2 hours
|
Incremental area under the glucose response curve ignoring area below fasting glucose
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satiety AUC
Time Frame: 2 hours
|
Incremental area under the satiety response curve
|
2 hours
|
Hydrolysis index
Time Frame: 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.
|
2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas MS Wolever, MD, PhD, GI Labs
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 3, 2014
Primary Completion (Actual)
June 13, 2014
Study Completion (Actual)
June 13, 2014
Study Registration Dates
First Submitted
July 19, 2017
First Submitted That Met QC Criteria
July 19, 2017
First Posted (Actual)
July 21, 2017
Study Record Updates
Last Update Posted (Actual)
July 21, 2017
Last Update Submitted That Met QC Criteria
July 19, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- GIL-1426
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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