A Study to Examine the Glycemic Response of Corn and Soy Tortillas in Healthy Individuals

NCT01828671 | Completed

• 2 other identifiers: SOYT-2013BREB:2013:031
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Tortillas are a staple food in several cultures and are widely used to make tacos, burritos, and enchiladas. These foods are gaining a significant segment of the North American fast food and restaurant industry. From a health point of view, the addition of soy flour into corn tortillas will improve the nutritional profile of the tortillas and the presence of soy protein, dietary fibre and bioactive components has the potential to yield other health benefits. It is hypothesized that the addition of soy flour to corn tortillas will lower the glycemic index which could benefit those individuals with type 2 diabetes. The purpose of this research is to investigate whether different levels of soy flour in corn tortillas influences the glycemic response.

Conditions

Healthy

Keywords

Soy; Corn; Flour; Tortilla; Glycemic; Glucose,; glycemic index

Outcome Measures

Primary Outcomes (1)

• Blood glucose as measured via capillary sampling using glucometer

  Blood will be sampled via capillary finger prick at time-point 0, (before the product is consumed), and 15, 30, 45, 60, 90 and 120 minutes after the first bite of the tortillas or first sip of the glucose solution to determine blood glucose concentrations using a glucometer.

  0, 15, 30, 45, 60, 90 and 120 minutes

Study Arms (5)

Oral Glucose Solution 296 ml

ACTIVE COMPARATOR

Study Participants will consume oral glucose solution 296 mls. Blood will be sampled via capillary at time-point 0 (before the product is consumed), and 15, 30, 45, 60, 90 and 120 minutes after consumption to determine blood glucose concentrations using a glucometer. Per standard glycemic index testing protocols, this will be repeated at another visit.

Other: Corn Tortilla; Other: Low Soy Flour Corn Tortilla; Other: Moderate Soy Flour Corn Tortilla; Other: High Soy Flour Corn Tortilla

Corn Tortilla

ACTIVE COMPARATOR

Study Participants will consume 2 to 3.5 corn tortillas (12-15 cm in diameter each) with a total serving of 25 grams of available carbohydrate. Blood will be sampled via capillary at time-point 0 (before the product is consumed), and 15, 30, 45, 60, 90 and 120 minutes after consumption to determine blood glucose concentrations using a glucometer.

Other: Oral Glucose Solution 296 mls

Low Soy Flour Corn Tortilla

ACTIVE COMPARATOR

Study Participants will consume 2 to 3.5 tortillas (12-15 cm in diameter each) with a low amount of soy flour that is 25 grams of available carbohydrate. Blood will be sampled via capillary at time-point 0 (before the product is consumed), and 15, 30, 45, 60, 90 and 120 minutes after consumption to determine blood glucose concentrations using a glucometer.

Other: Oral Glucose Solution 296 mls

Moderate Soy Flour Corn Tortilla

ACTIVE COMPARATOR

Study Participants will consume 2 to 3.5 tortillas (12-15 cm in diameter each) with moderate amount of soy flour that has 25 grams of available carbohydrate. Blood will be sampled via capillary at time-point 0 (before the product is consumed), and 15, 30, 45, 60, 90 and 120 minutes after consumption to determine blood glucose concentrations using a glucometer.

Other: Oral Glucose Solution 296 mls

High Soy Flour Corn Tortilla

ACTIVE COMPARATOR

Study Participants will consume 2 to 3.5 tortillas (12-15 cm in diameter each) with a high amount soy flour that has 25 grams of available carbohydrate. Blood will be sampled via capillary at time-point 0 (before the product is consumed), and 15, 30, 45, 60, 90 and 120 minutes after consumption to determine blood glucose concentrations using a glucometer.

Other: Oral Glucose Solution 296 mls

Interventions

Oral Glucose Solution 296 mls OTHER

Should the participant be eligible to participate, they will be scheduled for two separate study visits to assess the glycemic response of the oral glucose solution.

Corn Tortilla; High Soy Flour Corn Tortilla; Low Soy Flour Corn Tortilla; Moderate Soy Flour Corn Tortilla

Corn Tortilla OTHER

Should the participant be eligible to participate, they will be scheduled for a study visit to assess the glycemic response of the corn tortillas.

Oral Glucose Solution 296 ml

Low Soy Flour Corn Tortilla OTHER

Should the participant be eligible to participate, they will be scheduled for a single study visit to assess the glycemic response of corn tortillas with a low amount of soy flour.

Oral Glucose Solution 296 ml

Moderate Soy Flour Corn Tortilla OTHER

Should the participant be eligible to participate, they will be scheduled for a single study visit to assess the glycemic response of corn tortillas with a moderate amount of soy flour.

Oral Glucose Solution 296 ml

High Soy Flour Corn Tortilla OTHER

Should the participant be eligible to participate, they will be scheduled for a single study visit to assess the glycemic response of corn tortillas with a high amount of soy flour.

Oral Glucose Solution 296 ml

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, greater or equal to 18 and less than or equal to 40 years of age;
• Normal blood lipid profile (total cholesterol, LDL-cholesterol, HDL- cholesterol, triglycerides) and glycated hemoglobin \<6%;
• Body mass index (BMI) of 20 to 30;
• Stable regime for the past 3 months if taking vitamin and mineral/dietary/herbal supplements;
• Agree not to eat soybeans (edamame) or soy-based foods, or consume soy or isoflavone supplements while participating in this study;
• Willing to comply with the protocol requirements;
• Willing to provide informed consent.

You may not qualify if:

• Allergies to corn or soy flour or to corn or soy products;
• Presence of a clinically diagnosed disease affecting the circulatory, respiratory, immune, skeletal, urinary, muscular, endocrine, digestive, nervous or reproductive system that requires medical treatment;
• Taking any prescribed medication (with the exception of birth control) within the last 3 months, or taking supplements which affect glycemic control within the last 3 months;
• Cigarette/cigar smoking, current or within the last 6 months;
• Current (within the last 30 days) bacterial, viral or fungal infection, or taking over-the-counter medication within the past 72 h;
• Pregnancy or lactation.

Sponsors & Collaborators

• University of Manitoba: lead
• Manitoba Pulse Growers: collaborator

Study Sites (1)

St. Boniface General Hospital - Asper Clinical Research Institute

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Related Publications (2)

• Brouns F, Bjorck I, Frayn KN, Gibbs AL, Lang V, Slama G, Wolever TM. Glycaemic index methodology. Nutr Res Rev. 2005 Jun;18(1):145-71. doi: 10.1079/NRR2005100.

  PMID: 19079901 BACKGROUND

• Makelainen H, Anttila H, Sihvonen J, Hietanen RM, Tahvonen R, Salminen E, Mikola M, Sontag-Strohm T. The effect of beta-glucan on the glycemic and insulin index. Eur J Clin Nutr. 2007 Jun;61(6):779-85. doi: 10.1038/sj.ejcn.1602561. Epub 2006 Dec 6.

  PMID: 17151593 RESULT

Related Links

• Canadian Center for Agri-Food Research in Health and Medicine

MeSH Terms

Conditions

Callosities

Condition Hierarchy (Ancestors)

Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Carla Taylor, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Principal Investigator

Study Record Dates

• First Submitted: April 7, 2013
• First Posted: April 11, 2013
• Study Start: December 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 15, 2014

Record last verified: 2014-05

Locations

CA (1)