DiabetesIGITNCT02294123
Glycemic Index and Insulinemic Index of 3 Types of Tortilla in Mexican Adults
A study testing 3 tortillas and white bread in people with Diabetes and Overweight, run by Mexican National Institute of Public Health at 1 site in Mexico.
Trial summary
Objective. To evaluate the effect of the intake of two types of whole corn tortilla and one traditional tortilla on glycemic index (GI) and insulinemic index (InIn) in adults with diabetes, or overweight or clinically healthy. Material and methods. Type crossover clinical trial in adults 20-69 years. Read more about this study
- Who is it for?
- Ages 20 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Overweight, Healthy
- What is being tested?
- 3 tortillas and white bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2013to Oct 2015
- 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 20 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- One group (n=27) with a diagnosis of type 2 diabetes documented by fasting blood glucose.
- One group (n=27) with overweight by Body Mass Index (BMI) >=25 kg/m2
- One group (n=27) with healthy adults without non communicable chronic diseases
Who cannot join
- Alterations associated with digestion and bariatric surgery
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Mexican National Institute of Public Health
Cuernavaca, Morelos, 62100
About this study
Official title: Glycemic Index and Insulinemic Index of 3 Types of Tortilla in Mexican Adults With Overweight or Diabetes or Clinically Healthy
Objective. To evaluate the effect of the intake of two types of whole corn tortilla and one traditional tortilla on glycemic index (GI) and insulinemic index (InIn) in adults with diabetes, or overweight or clinically healthy.
Material and methods. Type crossover clinical trial in adults 20-69 years. Three groups of participants will be included for each category (n = 27 in each group): 1) adults with diabetes, b) adults with overweight c) clinically healthy adults. The glycemic and insulinemic index will be measure for each group of participants given in random order the following foods: 1) a whole corn tortilla (white "criollo" corn= 5.3% fiber), 2) a whole corn tortilla (white "hybrid" corn= 7.9%), 3) a traditional corn tortilla (3.9% fiber), and 4) white bread (reference food containing 2.2% of fiber). For the calculation of GI and InIn will be follow the "FAO" methodology. For the evaluation of each food left the range of 1 week.
Read the detailed description
Objective. To evaluate the effect of the intake of two types of whole corn tortilla, and one traditional tortilla on Glycemic Index (GI) and Insulinemic Index (InIn) in adults with diabetes, or overweight or clinically healthy.
Material and methods. A randomised crossover, single-blinded study design will be undertake in adults 20-69 years. The study will use 3-arm: 1) Adults with diabetes (n=27); b) adults with overweight (n=27); and c) clinically healthy adults (n=27). During a week run-in period subjects will record their normal habitual diet for 7d. Individuals will be request to maintain their normal exercise, and sleeping patterns before reporting for testing.
Upon arrival to the laboratory, participants will be weight and body composition was determined. Overnight fasted (8-12 hours) participants reported to the Research Center of Mexican National Institute of Public Health on 4 occasions separated by at least one week. The glycemic and insulinemic index will be measure for each group of participants given in random order the following foods with a 1-week washout period in between: 1) a whole corn tortilla (white "criollo" corn= 5.3% fiber), 2) a whole corn tortilla (white "hybrid" corn= 7.9%), 3) a traditional corn tortilla (3.9% fiber), and 4) white bread (reference food containing 2.2% of fiber). The rations shall be 50g of carbohydrates available each (approximately equivalent to 4 tortillas or 4 breads, respectively).
Blood samples were collected again at 0, 15, 30, 45, 60, 90 and 120 minutes after completion of the test meal. Insulin and glucose will be measure by electrochemiluminescence and the hexokinase method, respectively. The GI values were determined according to Food and Agriculture Organization of the United Nations (FAO). The area under the curve will be calculated as the incremental area under the blood glucose response curve for each test in each individual. This study and the sampling of the volunteers were performed following approval of the ethics Committee of Mexican National Public Health Institute
- Conditions
- Diabetes, Overweight, Healthy
- Being tested
- 3 tortillas and white bread
- Medical subject headings
- Diabetes Mellitus, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 tortillas and white breadOther
Also called Glicemic index and insulinemic index
Type crossover clinical trial in adults 20-69 years. Three groups of participants were included for each category (n = 27 in each group): 1) adults with diabetes, b) adults with overweight c) clinically healthy adults. The glycemic and insulinemic index was measured for each group of participants given in random order the 3 types of Tortilla and white bread
| Study group | Role | What they receive |
|---|---|---|
| Diabetes (3 tortillas and white bread) | Experimental | Each participants (n=27) receive in random order the following foods: 1) a whole corn tortilla (white "criollo" corn= 5.3% fiber), 2) a whole corn tortilla (white "hybrid" corn= 7.9%), 3) a traditional corn tortilla (3.9% fiber), and 4) white bread (reference food containing 2.2% of fiber). Receives: Other: 3 tortillas and white bread |
| Overweight (3 tortillas and white bread) | Experimental | Each participants (n=27) receive in random order the following foods: 1) a whole corn tortilla (white "criollo" corn= 5.3% fiber), 2) a whole corn tortilla (white "hybrid" corn= 7.9%), 3) a traditional corn tortilla (3.9% fiber), and 4) white bread (reference food containing 2.2% of fiber). Receives: Other: 3 tortillas and white bread |
| Healthy (3 tortillas and white bread) | Experimental | Each participants (n=27) receive in random order the following foods: 1) a whole corn tortilla (white "criollo" corn= 5.3% fiber), 2) a whole corn tortilla (white "hybrid" corn= 7.9%), 3) a traditional corn tortilla (3.9% fiber), and 4) white bread (reference food containing 2.2% of fiber). Receives: Other: 3 tortillas and white bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic index
Blood glucose concentration increase after food intakes (3 types of tortilla and white bread)
Measured: 2 hours
Insulinemic index
Blood insulin concentration increase after food intakes (3 types of tortilla and white bread)
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startSep 2013
- Primary completionJun 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mexican National Institute of Public Health
- Sponsor type
- Other government
- Collaborators
- National Council of Science and Technology, Mexico
- Responsible party
- Principal investigator, Simon Barquera, MD, MS, PhD, Mexican National Institute of Public Health
- Investigators
- Simon Barquera, PhD, Principal investigator, Mexican Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294123
- Sponsor's protocol ID
- 120-6526
- Acronym
- IGIT
- Status last verified
- Sep 2015
- First submitted
- 14 Nov 2014
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Index and Insulinemic Index of 3 Types of Tortilla in Mexican Adults With Overweight or Diabetes or Clinically Healthy
- ClinicalTrials.gov ID
- NCT02294123
- Acronym / sponsor ID
- IGIT / 120-6526
- Conditions
- Diabetes, Overweight, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Mexican National Institute of Public HealthOther government
- Collaborators
- National Council of Science and Technology, Mexico
- Study start
- Sep 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 19 Nov 2014 (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.
Objective. To evaluate the effect of the intake of two types of whole corn tortilla and one traditional tortilla on glycemic index (GI) and insulinemic index (InIn) in adults with diabetes, or overweight or clinically healthy.
Material and methods. Type crossover clinical trial in adults 20-69 years. Three groups of participants will be included for each category (n = 27 in each group): 1) adults with diabetes, b) adults with overweight c) clinically healthy adults. The glycemic and insulinemic index will be measure for each group of participants given in random order the following foods: 1) a whole corn tortilla (white "criollo" corn= 5.3% fiber), 2) a whole corn tortilla (white "hybrid" corn= 7.9%), 3) a traditional corn tortilla (3.9% fiber), and 4) white bread (reference food containing 2.2% of fiber). For the calculation of GI and InIn will be follow the "FAO" methodology. For the evaluation of each food left the range of 1 week.
Detailed description
Objective. To evaluate the effect of the intake of two types of whole corn tortilla, and one traditional tortilla on Glycemic Index (GI) and Insulinemic Index (InIn) in adults with diabetes, or overweight or clinically healthy.
Material and methods. A randomised crossover, single-blinded study design will be undertake in adults 20-69 years. The study will use 3-arm: 1) Adults with diabetes (n=27); b) adults with overweight (n=27); and c) clinically healthy adults (n=27). During a week run-in period subjects will record their normal habitual diet for 7d. Individuals will be request to maintain their normal exercise, and sleeping patterns before reporting for testing.
Upon arrival to the laboratory, participants will be weight and body composition was determined. Overnight fasted (8-12 hours) participants reported to the Research Center of Mexican National Institute of Public Health on 4 occasions separated by at least one week. The glycemic and insulinemic index will be measure for each group of participants given in random order the following foods with a 1-week washout period in between: 1) a whole corn tortilla (white "criollo" corn= 5.3% fiber), 2) a whole corn tortilla (white "hybrid" corn= 7.9%), 3) a traditional corn tortilla (3.9% fiber), and 4) white bread (reference food containing 2.2% of fiber). The rations shall be 50g of carbohydrates available each (approximately equivalent to 4 tortillas or 4 breads, respectively).
Blood samples were collected again at 0, 15, 30, 45, 60, 90 and 120 minutes after completion of the test meal. Insulin and glucose will be measure by electrochemiluminescence and the hexokinase method, respectively. The GI values were determined according to Food and Agriculture Organization of the United Nations (FAO). The area under the curve will be calculated as the incremental area under the blood glucose response curve for each test in each individual. This study and the sampling of the volunteers were performed following approval of the ethics Committee of Mexican National Public Health Institute
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diabetes (3 tortillas and white bread) | Experimental | Other: 3 tortillas and white breadEach participants (n=27) receive in random order the following foods: 1) a whole corn tortilla (white "criollo" corn= 5.3% fiber), 2) a whole corn tortilla (white "hybrid" corn= 7.9%), 3) a traditional corn tortilla (3.9% fiber), and 4) white bread (reference food containing 2.2% of fiber). |
| Overweight (3 tortillas and white bread) | Experimental | Other: 3 tortillas and white breadEach participants (n=27) receive in random order the following foods: 1) a whole corn tortilla (white "criollo" corn= 5.3% fiber), 2) a whole corn tortilla (white "hybrid" corn= 7.9%), 3) a traditional corn tortilla (3.9% fiber), and 4) white bread (reference food containing 2.2% of fiber). |
| Healthy (3 tortillas and white bread) | Experimental | Other: 3 tortillas and white breadEach participants (n=27) receive in random order the following foods: 1) a whole corn tortilla (white "criollo" corn= 5.3% fiber), 2) a whole corn tortilla (white "hybrid" corn= 7.9%), 3) a traditional corn tortilla (3.9% fiber), and 4) white bread (reference food containing 2.2% of fiber). |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- One group (n=27) with a diagnosis of type 2 diabetes documented by fasting blood glucose.
- One group (n=27) with overweight by Body Mass Index (BMI) >=25 kg/m2
- One group (n=27) with healthy adults without non communicable chronic diseases
Key exclusion criteria (1 listed)
- Alterations associated with digestion and bariatric surgery
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 |
|---|---|---|
| 3 tortillas and white breadAlso: Glicemic index and insulinemic indexType crossover clinical trial in adults 20-69 years. Three groups of participants were included for each category (n = 27 in each group): 1) adults with diabetes, b) adults with overweight c) clinically healthy adults. The glycemic and insulinemic index was measured for each group of participants given in random order the 3 types of Tortilla and white bread | Other | Diabetes (3 tortillas and white bread), Healthy (3 tortillas and white bread), Overweight (3 tortillas and white bread) |
Primary outcome
Glycemic index
Time frame: 2 hours
Blood glucose concentration increase after food intakes (3 types of tortilla and white bread)
Insulinemic index
Time frame: 2 hours
Blood insulin concentration increase after food intakes (3 types of tortilla and white bread)
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 16 Mar 2016.
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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.
Simon Barquera, PhD principal investigator
Mexican Institute of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 tortillas and white bread in people with Diabetes and Overweight, run by Mexican National Institute of Public Health at 1 site in Mexico.
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 3 inclusion and 1 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 16 Mar 2016. 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 Mexico. 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?
Glycemic index (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2016.