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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03224806
Other study ID # GIL-1426
Secondary ID
Status Completed
Phase N/A
First received July 19, 2017
Last updated July 19, 2017
Start date June 3, 2014
Est. completion date June 13, 2014

Study information

Verified date July 2017
Source Glycemic Index Laboratories, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date June 13, 2014
Est. primary completion date June 13, 2014
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada Glycemic Index Laboratories, Inc. Toronto Ontario

Sponsors (3)

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

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glucose AUC Incremental area under the glucose response curve ignoring area below fasting glucose 2 hours
Secondary Satiety AUC Incremental area under the satiety response curve 2 hours
Secondary 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. 2 hours
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