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

September 3, 2014 updated by: Leticia Elizondo-Montemayor, Instituto Tecnologico y de Estudios Superiores de Monterey

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64710
        • Clinical Nutrition and Obesity Research Center. School of Medicine and Health Sciences, TEC Salud, Tecnológico de Monterrey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Mango puree and pear juice beverage
Participants will drink 450 milliliters of the juice at time 0.
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.
Other Names:
  • Determination of glycemic index of MPPJB.
OTHER: Commercial mango juice
Participants will drink 450 milliliters of the juice at time 0.
Other: 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.
Other Names:
  • Determination of glycemic index of commercial mango juice
OTHER: Fresh natural mango
Participants will eat 400 to 500 grams of frozen mango pulp, along with 250 milliliters of water at time 0.
Other: 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.
Other Names:
  • Determination of glycemic index of fresh natural mango
OTHER: Frozen natural mango
Participants will eat 400 to 500 grams of frozen mango pulp, along with 250 milliliters of water at time 0.
Other: 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.
Other Names:
  • Determination of glycemic index of frozen natural mango
OTHER: Processed natural mango pulp
Participants will eat 400 to 500 grams of frozen mango pulp, along with 250 milliliters of water at time 0.
Other: 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.
Other Names:
  • Determination of glycemic index of PNMP.
OTHER: Mix of natural mango and pear
Participants will eat 400 to 500 grams of a mixture of fresh natural fruit containing mango (73%) and pear (27%), along with 250 milliliters of water at time 0.
Other: 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.
Other Names:
  • Determination of glycemic index for mix of NMP.
OTHER: 50 grams glucose load
Participants will drink 250 milliliters of the standard glucose load at time 0.
Other: 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.
Other Names:
  • Determination of glycemic index for 50 grams glucose load

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic index of mango puree with natural pear juice beverage
Time Frame: 8 days
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic index of a commercial mango juice
Time Frame: 8 days
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
Glycemic index of natural fresh mango
Time Frame: 8 days
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
Glycemic index of natural frozen mango pulp
Time Frame: 8 days
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
Glycemic index of processed natural mango pulp
Time Frame: 8 days
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
glycemic index of a mixture of fresh mango 73 percent and fresh pear 27 percent
Time Frame: 8 days
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
glycemic index of a 50 gram glucose load
Time Frame: 8 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Tecnologico y de Estudios Superiores de Monterey

Investigators

  • Principal Investigator: Leticia Elizondo-Montemayor, MD, Clinical Nutrition and Obesity Research Center. TEC Salud, School of Medicine and Health Sciences. Instituto Tecnologico y de Estudios Superiores de Monterrey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

August 23, 2013

First Submitted That Met QC Criteria

August 23, 2013

First Posted (ESTIMATE)

August 28, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 4, 2014

Last Update Submitted That Met QC Criteria

September 3, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IGPMJP2013-CINCO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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