Clinical trial NCT03224806: Effect of Fiber Composite-enriched Breads on Glycemic Responses
Official title: Effect of Fiber Composite-enriched Breads on Glycemic Responses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycemic Response
Lead sponsor: Glycemic Index Laboratories, Inc
Sponsor class: INDUSTRY
Collaborators: name: University of Guelph
name: Guelph Research and Development Centre, Agriculture and Agri-Food Canada
First posted: 2017-07-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Glucose AUC
timeFrame: 2 hours
Secondary outcomes:
measure: Satiety AUC
timeFrame: 2 hours
measure: Hydrolysis index
timeFrame: 2 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Glycemic Index Laboratories, Inc.
state: Ontario
Study officials:
affiliation: GI Labs
name: Thomas MS Wolever, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: