Glycemic and Insulinemic Impact of Selected Canadian Beans

NCT ID: NCT02907190

Last Updated: 2016-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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Impaired Glucose Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Bean Type

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

Group Type EXPERIMENTAL

Bean Type

Intervention Type OTHER

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

Starchy Foods

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

Group Type ACTIVE_COMPARATOR

Starchy Foods

Intervention Type OTHER

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

Interventions

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Bean Type

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

Intervention Type OTHER

Starchy Foods

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

Intervention Type OTHER

Eligibility Criteria

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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.

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Glycemic Index Laboratories, Inc

INDUSTRY

Sponsor Role collaborator

Ontario Bean Growers Association

UNKNOWN

Sponsor Role collaborator

Guelph Food Research Centre

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dan Ramdath

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dan Ramdath, PhD

Role: PRINCIPAL_INVESTIGATOR

GI Laboratories Inc.

Locations

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Glycemic Index Laboratories, Inc

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 3942088 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 27497151 (View on PubMed)

Other Identifiers

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GIL-1625-lentil study

Identifier Type: -

Identifier Source: org_study_id

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