NCT01929551

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

September 4, 2014

Status Verified

September 1, 2014

Enrollment Period

2 months

First QC Date

August 23, 2013

Last Update Submit

September 3, 2014

Conditions

Keywords

glycemic index

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Glycemic index of a commercial mango juice

    8 days

  • Glycemic index of natural fresh mango

    8 days

  • Glycemic index of natural frozen mango pulp

    8 days

  • Glycemic index of processed natural mango pulp

    8 days

  • glycemic index of a mixture of fresh mango 73 percent and fresh pear 27 percent

    8 days

  • +1 more secondary outcomes

Study Arms (7)

Mango puree and pear juice beverage

OTHER

Participants will drink 450 milliliters of the juice at time 0.

Other: Mango puree and pear juice beverage

Commercial mango juice

OTHER

Participants will drink 450 milliliters of the juice at time 0.

Other: Commercial mango juice

Fresh natural mango

OTHER

Participants will eat 400 to 500 grams of frozen mango pulp, along with 250 milliliters of water at time 0.

Other: Fresh natural mango

Frozen natural mango

OTHER

Participants will eat 400 to 500 grams of frozen mango pulp, along with 250 milliliters of water at time 0.

Other: Frozen natural mango

Processed natural mango pulp

OTHER

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

Mix of natural mango and pear

OTHER

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

50 grams glucose load

OTHER

Participants will drink 250 milliliters of the standard glucose load at time 0.

Other: 50 grams glucose load

Interventions

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.

Also known as: Determination of glycemic index of MPPJB.
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.

Also known as: Determination of glycemic index of commercial mango juice
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.

Also known as: Determination of glycemic index of fresh natural mango
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.

Also known as: Determination of glycemic index of frozen natural mango
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.

Also known as: Determination of glycemic index of PNMP.
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.

Also known as: Determination of glycemic index for mix of NMP.
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.

Also known as: Determination of glycemic index for 50 grams glucose load
50 grams glucose load

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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:
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition and Obesity Research Center. School of Medicine and Health Sciences, TEC Salud, Tecnológico de Monterrey

Monterrey, Nuevo León, 64710, Mexico

Location

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MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

August 23, 2013

First Posted

August 28, 2013

Study Start

August 1, 2013

Primary Completion

October 1, 2013

Study Completion

November 1, 2013

Last Updated

September 4, 2014

Record last verified: 2014-09

Locations