Clinical trial NCT01929551: Glycemic Index of Mango and Pear in Different Solid Products and Drinks
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Intolerance
Keywords: glycemic index
Lead sponsor: Instituto Tecnologico y de Estudios Superiores de Monterey
Sponsor class: OTHER
First posted: 2013-08-28
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycemic index of mango puree with natural pear juice beverage
timeFrame: 8 days
Secondary outcomes:
measure: Glycemic index of a commercial mango juice
timeFrame: 8 days
measure: Glycemic index of natural fresh mango
timeFrame: 8 days
measure: Glycemic index of natural frozen mango pulp
timeFrame: 8 days
measure: Glycemic index of processed natural mango pulp
timeFrame: 8 days
measure: glycemic index of a mixture of fresh mango 73 percent and fresh pear 27 percent
timeFrame: 8 days
measure: glycemic index of a 50 gram glucose load
timeFrame: 8 days
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Clinical Nutrition and Obesity Research Center. School of Medicine and Health Sciences, TEC Salud, Tecnológico de Monterrey
state: Nuevo Leon
Study officials:
affiliation: Clinical Nutrition and Obesity Research Center. TEC Salud, School of Medicine and Health Sciences. Instituto Tecnologico y de Estudios Superiores de Monterrey
name: Leticia Elizondo-Montemayor, MD
role: PRINCIPAL_INVESTIGATOR
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