Glycemic Index and Insulinemic Index of 3 Types of Tortilla in Mexican Adults (IGIT)

• ClinicalTrials.gov Identifier: NCT02294123
• Recruitment Status: Completed
• First Posted: November 19, 2014
• Last Update Posted: March 16, 2016
• Sponsor: Mexican National Institute of Public Health
• Collaborator: National Council of Science and Technology, Mexico
• Information provided by (Responsible Party): Simon Barquera, MD, MS, PhD, Mexican National Institute of Public Health

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Diabetes; Overweight; Healthy	Other: 3 tortillas and white bread	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 81 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Official Title: Glycemic Index and Insulinemic Index of 3 Types of Tortilla in Mexican Adults With Overweight or Diabetes or Clinically Healthy
• Study Start Date: September 2013
• Actual Primary Completion Date: June 2015
• Actual Study Completion Date: October 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Diabetes (3 tortillas and white bread); 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; 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; Other Name: Glicemic index and insulinemic index
Experimental: Overweight (3 tortillas and white bread); 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; 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; Other Name: Glicemic index and insulinemic index
Experimental: Healthy (3 tortillas and white bread); 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; 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; Other Name: Glicemic index and insulinemic index

Outcome Measures

Primary Outcome Measures :

1. Glycemic index [ Time Frame: 2 hours ]
   Blood glucose concentration increase after food intakes (3 types of tortilla and white bread)
2. Insulinemic index [ Time Frame: 2 hours ]
   Blood insulin concentration increase after food intakes (3 types of tortilla and white bread)

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 69 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Mexico

Mexican National Institute of Public Health

Cuernavaca,, Morelos, Mexico, 62100

Sponsors and Collaborators

Mexican National Institute of Public Health

National Council of Science and Technology, Mexico

Investigators

• Principal Investigator: Simon Barquera, PhD; Mexican Institute of Public Health

More Information

• Responsible Party: Simon Barquera, MD, MS, PhD, Director of Policies and Programs in Nutrition, Mexican National Institute of Public Health
• ClinicalTrials.gov Identifier: NCT02294123
• Other Study ID Numbers: 120-6526
• First Posted: November 19, 2014
• Last Update Posted: March 16, 2016
• Last Verified: September 2015

Additional relevant MeSH terms:

Overweight; Body Weight