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Glycemic and Insulinemic Impact of Selected Canadian Beans (MED-beans)

Primary Purpose

Impaired Glucose Tolerance

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Bean Type

Starchy Foods

About this trial

This is an interventional basic science trial for Impaired Glucose Tolerance focused on measuring pulses, beans, blood glucose, insulin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Glycemic Index Laboratories, Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bean Type

Starchy Foods

Arm Description

Beans (black; cranberry; great northern; navy; pinto; red) soaked overnight and boiled. 1/2 cup serving eaten by participants at study visit

1/2 cup serving of rice or paste or potato or corn will be eaten by participants on different study visit

Outcomes

Primary Outcome Measures

Glycemic Response

post prandial blood glucose response

Secondary Outcome Measures

Insulin Response

post prandial blood insulin response

Full Information

NCT ID

NCT02907190

First Posted

September 15, 2016

Last Updated

September 19, 2016

Sponsor

Guelph Food Research Centre

Collaborators

Glycemic Index Laboratories, Inc, Ontario Bean Growers Association

1. Study Identification

Unique Protocol Identification Number

NCT02907190

Brief Title

Glycemic and Insulinemic Impact of Selected Canadian Beans

Acronym

MED-beans

Official Title

Glycemic and Insulinemic Impact of Selected Canadian Beans

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

March 2016 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guelph Food Research Centre

Collaborators

Glycemic Index Laboratories, Inc, Ontario Bean Growers Association

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Impaired Glucose Tolerance

Keywords

pulses, beans, blood glucose, insulin

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bean Type

Arm Type

Experimental

Arm Description

Beans (black; cranberry; great northern; navy; pinto; red) soaked overnight and boiled. 1/2 cup serving eaten by participants at study visit

Arm Title

Starchy Foods

Arm Type

Active Comparator

Arm Description

1/2 cup serving of rice or paste or potato or corn will be eaten by participants on different study visit

Intervention Type

Other

Intervention Name(s)

Bean Type

Intervention Description

1/2 cup of freshly boiled beans will be eaten by participants on separate study visits

Intervention Type

Other

Intervention Name(s)

Starchy Foods

Intervention Description

1/2 cup serving of one of 4 starchy foods will be eaten by participants on different study visit

Primary Outcome Measure Information:

Title

Glycemic Response

Description

post prandial blood glucose response

Time Frame

120 minutes

Secondary Outcome Measure Information:

Title

Insulin Response

Description

post prandial blood insulin response

Time Frame

120 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dan Ramdath, PhD

Organizational Affiliation

GI Laboratories Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Glycemic Index Laboratories, Inc

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5C 2N8

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

Citation

EFSA 2011: European Food Safety Authority, Scientific Opinion on the substantiation of health claims related to resistant starch and reduction of post-prandial glycaemic responses (ID 681), "digestive health benefits" (ID 682) and "favours a normal colon metabolism" (ID 783) pursuant to Article 13(1) of Regulation (EC) No 1924/20061. EFSA Journal 9(4):2024.

Results Reference

background

Citation

EFSA: European Food Safety Authority, Panel on Dietetic Products, Nutrition and Allergies (NDA). 2012. Scientific Opinion. Guidance on the scientific requirements for health claims related to appetite ratings, weight management and blood glucose concentrations. EFSA Journal 10(3): 2604-2614.

Results Reference

background

Citation

Health Canada. Bureau of Nutritional Sciences, food directorate, health products and food branch. June 2013. Draft guidance document on food health claims related to the reduction in post-prandial glycaemic response.

Results Reference

background

PubMed Identifier

3942088

Citation

Wolever TM, Jenkins DJ. The use of the glycemic index in predicting the blood glucose response to mixed meals. Am J Clin Nutr. 1986 Jan;43(1):167-72. doi: 10.1093/ajcn/43.1.167.

Results Reference

background

Citation

Wolever TMS (2006). The Glycaemic Index: A Physiological Classification of Dietary Carbohydrate. CABI Publishing, Wallingford, UK.

Results Reference

background

PubMed Identifier

27497151

Citation

Ramdath D, Renwick S, Duncan AM. The Role of Pulses in the Dietary Management of Diabetes. Can J Diabetes. 2016 Aug;40(4):355-63. doi: 10.1016/j.jcjd.2016.05.015.

Results Reference

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Glycemic and Insulinemic Impact of Selected Canadian Beans

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