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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02907190
First Posted: September 20, 2016
Last Update Posted: September 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Glycemic Index Laboratories, Inc
Ontario Bean Growers Association
Information provided by (Responsible Party):
Dan Ramdath, Guelph Food Research Centre
  Purpose
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.

Condition Intervention
Impaired Glucose Tolerance Other: Bean Type Other: Starchy Foods

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Glycemic and Insulinemic Impact of Selected Canadian Beans

Further study details as provided by Dan Ramdath, Guelph Food Research Centre:

Primary Outcome Measures:
  • Glycemic Response [ Time Frame: 120 minutes ]
    post prandial blood glucose response


Secondary Outcome Measures:
  • Insulin Response [ Time Frame: 120 minutes ]
    post prandial blood insulin response


Enrollment: 18
Study Start Date: March 2016
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907190


Locations
Canada, Ontario
Glycemic Index Laboratories, Inc
Toronto, Ontario, Canada, M5C 2N8
Sponsors and Collaborators
Guelph Food Research Centre
Glycemic Index Laboratories, Inc
Ontario Bean Growers Association
Investigators
Principal Investigator: Dan Ramdath, PhD GI Laboratories Inc.
  More Information

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

Responsible Party: Dan Ramdath, Research Scientist, Guelph Food Research Centre
ClinicalTrials.gov Identifier: NCT02907190     History of Changes
Other Study ID Numbers: GIL-1625-lentil study
First Submitted: September 15, 2016
First Posted: September 20, 2016
Last Update Posted: September 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dan Ramdath, Guelph Food Research Centre:
pulses
beans
blood glucose
insulin

Additional relevant MeSH terms:
Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases