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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01929551
• Other study ID #: IGPMJP2013-CINCO
• Status: Completed
• Phase: N/A
• First received: August 23, 2013
• Last updated: September 3, 2014
• Start date: August 2013
• Est. completion date: November 2013

Study information

• Verified date: September 2014
• Source: Instituto Tecnologico y de Estudios Superiores de Monterey
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Men and women

• Ages 18 to 50 years

• Body mass index between 18.5 and 27.4 kilograms divided by squared meters

• Waist circumference = 102 centimeters for men and =88 centimeters for women

• Fasting capillary glucose =100 milligrams per deciliter

The night before the study:

• 10 hours fasting

• Light dinner of their choice and repeat it every time before the study

• No alcohol, coffee or tea drinks the previous night

• No vigorous exercise the day before the test nor the morning of the test

Exclusion Criteria:

• Consumption of any of the following: oral hypoglycemic drugs, oral or parenteral glucocorticoid drugs, thyroid hormones, stimulant of intestinal motility or other drugs that may interfere with the intestinal absorption during the test

• Acute or chronic gastrointestinal infections

• Breast feeding or pregnant women

• Intestinal surgeries in the last 6 months

• Allergies to any of the products we will be using

• Subjects with gastrointestinal or metabolic diseases

• Subjects with first grade family history of diabetes mellitus

• Subjects with glucose intolerance, insulin resistance or diabetes mellitus

• Subjects who dislike any of the products we will be using

• Subjects with an acute (previous 24 hours) digestive crisis including: gastritis, diarrhea, and vomit, among others

• Subjects with a history of mal-absorption

Suspension:

• Subjects that do not arrive at the test-day

• Fasting glucose = 100 milligrams per deciliter the day of the test

• Subjects who develop gastrointestinal disease during the study time frame

Study Design

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

Related Conditions & MeSH terms

• Glucose Intolerance

Intervention

Other:
• Mango puree and pear juice beverage
Capillary glucose will be taken every 15 minutes for two hours (starting at time 0) to calculate the area under the curve which is the glycemic index, for each of the products.
• Commercial mango juice
Capillary glucose will be taken every 15 minutes for two hours (starting at time 0) to calculate the area under the curve which is the glycemic index, for each of the products.
• Fresh natural mango
Capillary glucose will be taken every 15 minutes for two hours (starting at time 0) to calculate the area under the curve which is the glycemic index, for each of the products.
• Frozen natural mango
Capillary glucose will be taken every 15 minutes for two hours (starting at time 0) to calculate the area under the curve which is the glycemic index, for each of the products.
• Processed natural mango pulp
Capillary glucose will be taken every 15 minutes for two hours (starting at time 0) to calculate the area under the curve which is the glycemic index, for each of the products.
• Mix of natural mango and pear
Capillary glucose will be taken every 15 minutes for two hours (starting at time 0) to calculate the area under the curve which is the glycemic index, for each of the products.
• 50 grams glucose load
Capillary glucose will be taken every 15 minutes for two hours (starting at time 0) to calculate the area under the curve which is the glycemic index, for each of the products.

Locations

Country	Name	City	State
Mexico	Clinical Nutrition and Obesity Research Center. School of Medicine and Health Sciences, TEC Salud, Tecnológico de Monterrey	Monterrey	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Tecnologico y de Estudios Superiores de Monterey

Country where clinical trial is conducted

Mexico, 

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic index of mango puree with natural pear juice beverage	Glycemic index will be calculated for 450 milliliters of this juice. The results will be expressed as mean ± standard deviation for each with a significance level of 0.05 for all the statistical tests.	8 days	No
Secondary	Glycemic index of a commercial mango juice	Glycemic index will be calculated for 450 milliliters of this juice. The results will be expressed as mean ± standard deviation for each with a significance level of 0.05 for all the statistical tests.	8 days	No
Secondary	Glycemic index of natural fresh mango	Glycemic index will be calculated for 400 to 500 grams of mango along with 250 milliliters of water. The results will be expressed as mean ± standard deviation for each with a significance level of 0.05 for all the statistical tests.	8 days	No
Secondary	Glycemic index of natural frozen mango pulp	Glycemic index will be calculated for 400 to 500 grams of mango along with 250 milliliters of water. The results will be expressed as mean ± standard deviation for each with a significance level of 0.05 for all the statistical tests.	8 days	No
Secondary	Glycemic index of processed natural mango pulp	Glycemic index will be calculated for 400 to 500 grams of mango along with 250 milliliters of water. The results will be expressed as mean ± standard deviation for each with a significance level of 0.05 for all the statistical tests.	8 days	No
Secondary	glycemic index of a mixture of fresh mango 73 percent and fresh pear 27 percent	Glycemic index will be calculated for 400 to 500 grams of mango along with 250 milliliters of water. The results will be expressed as mean ± standard deviation for each with a significance level of 0.05 for all the statistical tests.	8 days	No
Secondary	glycemic index of a 50 gram glucose load	Glycemic index will be calculated for a standard 50-gram glucose load. This will be done twice by every participant. The results will be expressed as mean ± standard deviation for each with a significance level of 0.05 for all the statistical tests.	8 days	No