Glycemic Index and Insulinemic Index of 3 Types of Tortilla in Mexican Adults

Study Overview
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Brief Summary
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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
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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

Official Title
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Glycemic Index and Insulinemic Index of 3 Types of Tortilla in Mexican Adults With Overweight or Diabetes or Clinically Healthy

Conditions
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Diabetes, Overweight, Healthy

Intervention / Treatment
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* Other: 3 tortillas and white bread


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Alterations associated with digestion and bariatric surgery

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetes (3 tortillas and white bread)<br>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). | Other: 3 tortillas and white bread<br>* 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<br>* Other names: Glicemic index and insulinemic index;|
| Experimental: Overweight (3 tortillas and white bread)<br>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). | Other: 3 tortillas and white bread<br>* 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<br>* Other names: Glicemic index and insulinemic index;|
| Experimental: Healthy (3 tortillas and white bread)<br>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). | Other: 3 tortillas and white bread<br>* 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<br>* Other names: Glicemic index and insulinemic index;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic index | Blood glucose concentration increase after food intakes (3 types of tortilla and white bread) | 2 hours | 
| Insulinemic index | Blood insulin concentration increase after food intakes (3 types of tortilla and white bread) | 2 hours |