Glycemic and Insulinemic Impact of Selected Canadian Beans

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to compare the glycemic and insulinemic response elicited by ½ cup servings of 6 beans to those elicited by ½ cup servings of mashed potato, macaroni, rice and corn.

Detailed Description
-----------------
In order for a food to be able to claim a reduced glycemic response, it must be shown that a typical serving of the food elicits a significantly lower blood glucose responses compared to a serving of an appropriate control food. While many studies have examined the GI of beans, few studies have compared the glycemic impact of a typical serving of beans to a typical serving of other starchy foods. Therefore, there are insufficient data to allow for a claim that beans have a low glycemic response. In addition, in order to make a claim of a reduced glycemic response, regulatory agencies also require that the insulinemic response to a food is not disproportionately increased.

Official Title
-----------------
Glycemic and Insulinemic Impact of Selected Canadian Beans

Conditions
-----------------
Impaired Glucose Tolerance

Intervention / Treatment
-----------------
* Other: Bean Type
* Other: Starchy Foods


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or non-pregnant females, 18-75 years of age, inclusive Body mass index (BMI) < 40 kg/m² Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial and to refrain from smoking for 12hr prior to each visit. Normal fasting serum glucose (<7.0mmol/L capillary corresponding to whole blood glucose <6.3mmol/L). Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator. Exclusion Criteria: Failure to meet any one of the inclusion criteria Known history of AIDS, hepatitis, diabetes or a heart condition Subjects using medications or with any condition which might, in the opinion of Dr. Wolever, the Medical Director of GI Labs, either: 1) make participation dangerous to the subject or to others, or 2) affect the results. Major trauma or surgical event within 3 months of screening. Unwillingness or inability to comply with the experimental procedures and to follow GI Labs safety guidelines. Known intolerance, sensitivity or allergy to any ingredients in the study products.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bean Type<br>Beans (black; cranberry; great northern; navy; pinto; red) soaked overnight and boiled. 1/2 cup serving eaten by participants at study visit | Other: Bean Type<br>* 1/2 cup of freshly boiled beans will be eaten by participants on separate study visits<br>|
| Active Comparator: Starchy Foods<br>1/2 cup serving of rice or paste or potato or corn will be eaten by participants on different study visit | Other: Starchy Foods<br>* 1/2 cup serving of one of 4 starchy foods will be eaten by participants on different study visit<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic Response | post prandial blood glucose response | 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Response | post prandial blood insulin response | 120 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulses, beans, blood glucose, insulin