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

September 19, 2016 updated by: Dan Ramdath, Guelph Food Research Centre
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5C 2N8
        • 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

Yes

Genders Eligible for Study

All

Description

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.

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bean Type
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
1/2 cup of freshly boiled beans will be eaten by participants on separate study visits
Active Comparator: Starchy Foods
1/2 cup serving of rice or paste or potato or corn will be eaten by participants on different study visit
Other: Starchy Foods
1/2 cup serving of one of 4 starchy foods will be eaten by participants on different study visit

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guelph Food Research Centre

Collaborators

Glycemic Index Laboratories, Inc
Ontario Bean Growers Association

Investigators

  • Principal Investigator: Dan Ramdath, PhD, GI Laboratories Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

September 15, 2016

First Submitted That Met QC Criteria

September 19, 2016

First Posted (Estimate)

September 20, 2016

Study Record Updates

Last Update Posted (Estimate)

September 20, 2016

Last Update Submitted That Met QC Criteria

September 19, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIL-1625-lentil study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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