HealthySOYT-2013NCT01828671
A Study to Examine the Glycemic Response of Corn and Soy Tortillas in Healthy Individuals
A study testing Oral Glucose Solution 296 mls, Corn Tortilla and Low Soy Flour Corn Tortilla in people with Healthy, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Oral Glucose Solution 296 mls, Corn Tortilla and Low Soy Flour Corn Tortilla
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2013to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Boniface General Hospital - Asper Clinical Research Institute
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: A Double-Blind, Randomized, Controlled Study to Examine the Glycemic Response of Corn and Soy Tortillas in Healthy Individuals.
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.
Read the detailed description
Soybeans are an important crop in Canada, with approximately 10% of soybean production in Manitoba. Soybeans are grown primarily for their oil. The press cake that remains following oil extraction is a good source of protein and contains bioactive ingredients such as the isoflavones. The press cake can be ground into a flour (soy flour) and used in food products. For example, a finely ground flour can be used in infant formulas as well as for meat and dairy substitutes. This research is examining other applications of soy flour in food products such as corn tortillas. 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. The glycemic index describes the potential of a food to increase blood glucose post-prandially in relation to the same amount of available carbohydrate in a glucose solution. Consumption of low glycemic index foods helps to achieve better glycemic control in individuals with type 2 diabetes. Recent meta-analyses are reporting that consumption of high glycemic index foods is associated with higher risk of coronary heart disease and breast cancer in women.
The purpose of this research is to investigate whether different levels of soy flour in corn tortillas influences the glycemic response. This information will form the basis of developing food products for glycemic management in type 2 diabetes and for reducing risk of other chronic diseases.
This single site, double-blind, randomized, controlled study designed to examine the glycemic response to corn and soy tortillas in healthy individuals will recruit 10 eligible volunteers into the study who will visit the research clinic on 6 separate visits for the glycemic testing. At each visit, one of the following products will be consumed: i) 296 mls (~1 cup) of oral glucose solution; ii) 296 mls (~1 cup) of oral glucose solution for a duplicate assessment as per standard glycemic index testing protocols; iii) corn tortillas; iv) corn tortillas with a low amount of soy flour; v) corn tortillas with a moderate amount of soy flour; or vi) corn tortillas made with a higher amount of soy flour.
- Conditions
- Healthy
- Being tested
- Oral Glucose Solution 296 mls, Corn Tortilla, Low Soy Flour Corn Tortilla, Moderate Soy Flour Corn Tortilla, High Soy Flour Corn Tortilla
- Keywords
- Soy, Corn, Flour, Tortilla, Glycemic, Glucose,, glycemic index
- Medical subject headings
- Callosities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Glucose Solution 296 mlsOther
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 TortillaOther
Should the participant be eligible to participate, they will be scheduled for a study visit to assess the glycemic response of the corn tortillas.
Low Soy Flour Corn TortillaOther
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.
Moderate Soy Flour Corn TortillaOther
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.
High Soy Flour Corn TortillaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Oral Glucose Solution 296 mls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 15, 30, 45, 60, 90 and 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startDec 2013
- Primary completionApr 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Manitoba Pulse Growers
- Responsible party
- Principal investigator, Dr. Carla Taylor, University of Manitoba
- Investigators
- Carla Taylor, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828671
- Sponsor's protocol ID
- SOYT-2013
- Other IDs
- BREB:2013:031
- Acronym
- SOYT-2013
- Status last verified
- May 2014
- First submitted
- 7 Apr 2013
- Last updated
- 15 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19079901Makelainen 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.
PubMed 17151593
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Controlled Study to Examine the Glycemic Response of Corn and Soy Tortillas in Healthy Individuals.
- ClinicalTrials.gov ID
- NCT01828671
- Acronym / sponsor ID
- SOYT-2013 / SOYT-2013
- Conditions
- Healthy
- Keywords
- Soy, Corn, Flour, Tortilla, Glycemic, Glucose,, glycemic index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Manitoba Pulse Growers
- Study start
- Dec 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 11 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Soybeans are an important crop in Canada, with approximately 10% of soybean production in Manitoba. Soybeans are grown primarily for their oil. The press cake that remains following oil extraction is a good source of protein and contains bioactive ingredients such as the isoflavones. The press cake can be ground into a flour (soy flour) and used in food products. For example, a finely ground flour can be used in infant formulas as well as for meat and dairy substitutes. This research is examining other applications of soy flour in food products such as corn tortillas. 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. The glycemic index describes the potential of a food to increase blood glucose post-prandially in relation to the same amount of available carbohydrate in a glucose solution. Consumption of low glycemic index foods helps to achieve better glycemic control in individuals with type 2 diabetes. Recent meta-analyses are reporting that consumption of high glycemic index foods is associated with higher risk of coronary heart disease and breast cancer in women.
The purpose of this research is to investigate whether different levels of soy flour in corn tortillas influences the glycemic response. This information will form the basis of developing food products for glycemic management in type 2 diabetes and for reducing risk of other chronic diseases.
This single site, double-blind, randomized, controlled study designed to examine the glycemic response to corn and soy tortillas in healthy individuals will recruit 10 eligible volunteers into the study who will visit the research clinic on 6 separate visits for the glycemic testing. At each visit, one of the following products will be consumed: i) 296 mls (~1 cup) of oral glucose solution; ii) 296 mls (~1 cup) of oral glucose solution for a duplicate assessment as per standard glycemic index testing protocols; iii) corn tortillas; iv) corn tortillas with a low amount of soy flour; v) corn tortillas with a moderate amount of soy flour; or vi) corn tortillas made with a higher amount of soy flour.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Oral Glucose Solution 296 ml | Active comparator | Other: Corn Tortilla, Other: Low Soy Flour Corn Tortilla, Other: Moderate Soy Flour Corn Tortilla, Other: High Soy Flour Corn TortillaStudy 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. |
| Corn Tortilla | Active comparator | Other: Oral Glucose Solution 296 mlsStudy 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. |
| Low Soy Flour Corn Tortilla | Active comparator | Other: Oral Glucose Solution 296 mlsStudy 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. |
| Moderate Soy Flour Corn Tortilla | Active comparator | Other: Oral Glucose Solution 296 mlsStudy 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. |
| High Soy Flour Corn Tortilla | Active comparator | Other: Oral Glucose Solution 296 mlsStudy 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Glucose Solution 296 mlsShould 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. | Other | Corn Tortilla, High Soy Flour Corn Tortilla, Low Soy Flour Corn Tortilla, Moderate Soy Flour Corn Tortilla |
| Corn TortillaShould the participant be eligible to participate, they will be scheduled for a study visit to assess the glycemic response of the corn tortillas. | Other | Oral Glucose Solution 296 ml |
| Low Soy Flour Corn TortillaShould 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. | Other | Oral Glucose Solution 296 ml |
| Moderate Soy Flour Corn TortillaShould 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. | Other | Oral Glucose Solution 296 ml |
| High Soy Flour Corn TortillaShould 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. | Other | Oral Glucose Solution 296 ml |
Primary outcome
Blood glucose as measured via capillary sampling using glucometer
Time frame: 0, 15, 30, 45, 60, 90 and 120 minutes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2014.
- Background: PubMed 19079901Brouns 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.
- Results publication: PubMed 17151593Makelainen 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.
- Canadian Center for Agri-Food Research in Health and MedicineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla Taylor, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Glucose Solution 296 mls, Corn Tortilla and Low Soy Flour Corn Tortilla in people with Healthy, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose as measured via capillary sampling using glucometer (time frame: 0, 15, 30, 45, 60, 90 and 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01828671, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2014.