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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01929551
Recruitment Status : Completed
First Posted : August 28, 2013
Last Update Posted : September 4, 2014
Sponsor:
Information provided by (Responsible Party):
Leticia Elizondo-Montemayor, Instituto Tecnologico y de Estudios Superiores de Monterey

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.

Condition or disease Intervention/treatment Phase
Glucose Intolerance Other: Mango puree and pear juice beverage Other: Commercial mango juice Other: Fresh natural mango Other: Frozen natural mango Other: Processed natural mango pulp Other: Mix of natural mango and pear Other: 50 grams glucose load Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
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 Start Date : August 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : November 2013

Arm Intervention/treatment
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 Name: Determination of glycemic index of MPPJB.

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 Name: Determination of glycemic index of commercial mango juice

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 Name: Determination of glycemic index of fresh natural mango

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 Name: Determination of glycemic index of frozen natural mango

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 Name: Determination of glycemic index of PNMP.

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 Name: Determination of glycemic index for mix of NMP.

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 Name: Determination of glycemic index for 50 grams glucose load




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929551


Locations
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Mexico
Clinical Nutrition and Obesity Research Center. School of Medicine and Health Sciences, TEC Salud, Tecnológico de Monterrey
Monterrey, Nuevo Leon, Mexico, 64710
Sponsors and Collaborators
Instituto Tecnologico y de Estudios Superiores de Monterey
Investigators
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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:
Brand JC, Holt S, Saveny and Hanksy J. Plasma glucose correlates inversely with satiety and CCK. Proc Nutr Soc Aust 1990; 15: 209 (abstr).
Carlson JJ, Winkleby M, Gardner C, Ahn D. Plant-based food intake and cardiovascular disease (CVD) risk factor status in a national sample of ethnically diverse women (NHANES III) FASEB J. 2003a;17:A372.
Olaiz-Fernández, G., Rivera-Dommarco, J., Shamah-Levy, T., Rojas, R., Villalpando-Hernández, S., Hernández-Avila, M. & Sepúlveda, J. (2006) Encuesta Nacional de Salud y Nutrición. Cuernavaca, México: Instituto Nacional de Salud Pública. Available at: http://www.insp.mx/images/stories/ENSANUT/Docs/Ensanut2006.pdf (Accessed on June 2011)
Rakel: Integrative Medicine, 2nd ed. Saunders, Elsevier, 2007.
Zehner, L and Zehner W. Mixtures of fructose, sucrose and lactose as a low-calorie bulk sweetener with reduced glycemic index. United States Patent 7560443, 2003.

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Responsible Party: Leticia Elizondo-Montemayor, M.D., Instituto Tecnologico y de Estudios Superiores de Monterey
ClinicalTrials.gov Identifier: NCT01929551    
Other Study ID Numbers: IGPMJP2013-CINCO
First Posted: August 28, 2013    Key Record Dates
Last Update Posted: September 4, 2014
Last Verified: September 2014
Keywords provided by Leticia Elizondo-Montemayor, Instituto Tecnologico y de Estudios Superiores de Monterey:
glycemic index
Additional relevant MeSH terms:
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Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases