Glycemic Index of Mango and Pear in Different Solid Products and Drinks

Glucose Intolerance Clinical Trial

Official title: Comparison of the Glycemic Index of a Drink Made of Natural Concentrated Mango Puree With Natural Concentrated Pear Juice With That of Other Five Products Based on Mango and Pear in Different Solid Products and Drinks

Status Completed

Clinical Trial Summary

The purpose of this study is to compare the glycemic index of a beverage made of natural concentrated mango puree with natural concentrated pear juice with other five different products based on natural mango and pear ingredients in the form of fruit or juice against a control of 50-gram glucose load.

Clinical Trial Description

The participants will be recruited with an open invitation to participate, those who voluntarily accept, sign an informed consent, and meet the all inclusion criteria and none of the exclusion criteria will participate.

Each participant will receive a different product (of the seven products available) each day of the test (8 days in total), making sure everyone receives each one of the products. All products will be distributed in a randomized fashion for each of the participants. The 50-gram glucose load (gold standard) will be the reference or control, and will be taken twice by each subject in the test.

Each one of the products given will contain 50 grams of carbohydrate. The time given to consume the products will be 10 minutes total.

There will be a "wash out" period of three days in between each product.

The participants will eat the product and capillary glucose will be taken with a glucometer (Accu-Chek Performa System © 2009 Roche Diagnostics. Roche Products, México) at times: 0, 15, 30, 45, 60, 75, 90, 150 and 120 minutes. The glucometer will be calibrated with a standard glucose solution every day previous to the test. The results will be used to calculate the glycemic index. At the end of the 120 minutes, the participants will receive a questionnaire of digestive symptoms presented during the test.

The glycemic index will be calculated by the area under the curve for each product divided by the area under the curve for the 50-gram glucose load, multiplied by 100. The area under the curve used to calculate the glycemic index is the area that surpasses the basal line, excluding the area under the basal line according to the Food and Agriculture Organization (FAO) in 1998 (Brouns et al 2005).

All information collected will be emptied into a pre-designed database.

The differences between the different products ingested will be analyzed with the statistical test of analysis of variance (ANOVA) with a pre-test of homogeneity of variance Brown-Foryhte. In case of failure to find homogeneity in the variances the nonparametric ANOVA, the Kruskal-Wallis test, will be used. The results will be expressed as mean ± standard deviation for each with a significance level of 0.05 for all the statistical tests.

After ANOVA, Tuckey Multiple Comparisons test will be used to evaluate the pairwise relationship for each product. ;

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Glucose Intolerance

• NCT number: NCT01929551
• Study type: Interventional
• Source: Instituto Tecnologico y de Estudios Superiores de Monterey
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Completion date: November 2013