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

Healthy Clinical Trial

— IGIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02294123
• Other study ID #: 120-6526
• Status: Completed
• Phase: N/A
• First received: November 14, 2014
• Last updated: March 14, 2016
• Start date: September 2013
• Est. completion date: October 2015

Study information

• Verified date: September 2015
• Source: Mexican National Institute of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: October 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 69 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Diabetes
• Healthy
• Overweight

Intervention

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

Locations

Country	Name	City	State
Mexico	Mexican National Institute of Public Health	Cuernavaca,	Morelos

Sponsors (2)

Lead Sponsor	Collaborator
Mexican National Institute of Public Health	National Council of Science and Technology, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic index	Blood glucose concentration increase after food intakes (3 types of tortilla and white bread)	2 hours	Yes
Primary	Insulinemic index	Blood insulin concentration increase after food intakes (3 types of tortilla and white bread)	2 hours	Yes