Healthy Clinical Trial
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.
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
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)
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