Glycemic and Insulinemic Impact of Selected Canadian Beans

Impaired Glucose Tolerance Clinical Trial

— MED-beans  

Official title:

Glycemic and Insulinemic Impact of Selected Canadian Beans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02907190
• Other study ID #: GIL-1625-lentil study
• Status: Completed
• Phase: N/A
• First received: September 15, 2016
• Last updated: September 19, 2016
• Start date: March 2016
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Guelph Food Research Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Public Health Agency of Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Glucose Tolerance

Intervention

Other:
• Bean Type
1/2 cup of freshly boiled beans will be eaten by participants on separate study visits
• Starchy Foods
1/2 cup serving of one of 4 starchy foods will be eaten by participants on different study visit

Locations

Country	Name	City	State
Canada	Glycemic Index Laboratories, Inc	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Guelph Food Research Centre	Glycemic Index Laboratories, Inc, Ontario Bean Growers Association

Country where clinical trial is conducted

Canada, 

References & Publications (6)

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.

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. Review. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Response	post prandial blood glucose response	120 minutes	No
Secondary	Insulin Response	post prandial blood insulin response	120 minutes	No