Glucose IntoleranceNCT01929551
Glycemic Index of Mango and Pear in Different Solid Products and Drinks
A study testing Mango puree and pear juice beverage, Commercial mango juice and Fresh natural mango in people with Glucose Intolerance, run by Instituto Tecnologico y de Estudios Superiores de Monterey at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Intolerance
- What is being tested?
- Mango puree and pear juice beverage, Commercial mango juice and Fresh natural mango
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2013to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Clinical Nutrition and Obesity Research Center. School of Medicine and Health Sciences, TEC Salud, Tecnológico de Monterrey
Monterrey, Nuevo León, 64710
About this study
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
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.
Read the 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.
- Conditions
- Glucose Intolerance
- Being tested
- Mango puree and pear juice beverage, Commercial mango juice, Fresh natural mango, Frozen natural mango, Processed natural mango pulp
- Keywords
- glycemic index
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mango puree and pear juice beverageOther
Also called Determination of glycemic index of MPPJB.
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 juiceOther
Also called Determination of glycemic index of 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 mangoOther
Also called Determination of glycemic index of 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 mangoOther
Also called Determination of glycemic index of 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 pulpOther
Also called Determination of glycemic index of PNMP.
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 pearOther
Also called Determination of glycemic index for mix of NMP.
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 loadOther
Also called Determination of glycemic index for 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.
| Study group | Role | What they receive |
|---|---|---|
| Mango puree and pear juice beverage | Other | Participants will drink 450 milliliters of the juice at time 0. Receives: Other: Mango puree and pear juice beverage |
| Commercial mango juice | Other | Participants will drink 450 milliliters of the juice at time 0. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: 50 grams glucose load |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 days
Secondary outcomes (6)
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.
Measured: 8 days
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.
Measured: 8 days
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.
Measured: 8 days
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.
Measured: 8 days
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.
Measured: 8 days
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.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Glucose IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Tecnologico y de Estudios Superiores de Monterey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leticia Elizondo-Montemayor, Instituto Tecnologico y de Estudios Superiores de Monterey
- Investigators
- Leticia Elizondo-Montemayor, MD, Principal investigator, Clinical Nutrition and Obesity Research Center. TEC Salud, School of Medicine and Health Sciences. Instituto Tecnologico y de Estudios Superiores de Monterrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929551
- Sponsor's protocol ID
- IGPMJP2013-CINCO
- Status last verified
- Sep 2014
- First submitted
- 23 Aug 2013
- Last updated
- 4 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
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).
Brock DW, Davis CK, Irving BA, Rodriguez J, Barrett EJ, Weltman A, Taylor AG, Gaesser GA. A high-carbohydrate, high-fiber meal improves endothelial function in adults with the metabolic syndrome. Diabetes Care. 2006 Oct;29(10):2313-5. doi: 10.2337/dc06-0917. No abstract available.
PubMed 17003313Brouns F, Bjorck I, Frayn KN, Gibbs AL, Lang V, Slama G, Wolever TM. Glycaemic index methodology. Nutr Res Rev. 2005 Jun;18(1):145-71. doi: 10.1079/NRR2005100.
PubMed 19079901Carlson JJ, Eisenmann JC, Norman GJ, Ortiz KA, Young PC. Dietary fiber and nutrient density are inversely associated with the metabolic syndrome in US adolescents. J Am Diet Assoc. 2011 Nov;111(11):1688-95. doi: 10.1016/j.jada.2011.08.008.
PubMed 22027051Carlson JJ, Monti V. The role of inclusive dietary patterns for achieving secondary prevention cardiovascular nutrition guidelines and optimal cardiovascular health. J Cardiopulm Rehabil. 2003 Sep-Oct;23(5):322-33. doi: 10.1097/00008483-200309000-00001. No abstract available.
PubMed 14512776Carlson 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.
Delzenne NM, Cani PD. A place for dietary fibre in the management of the metabolic syndrome. Curr Opin Clin Nutr Metab Care. 2005 Nov;8(6):636-40. doi: 10.1097/01.mco.0000171124.06408.71.
PubMed 16205465Dubnov-Raz G, Berry EM. The dietary treatment of obesity. Endocrinol Metab Clin North Am. 2008 Dec;37(4):873-86. doi: 10.1016/j.ecl.2008.08.002.
PubMed 19026937Ellison JM, Stegmann JM, Colner SL, Michael RH, Sharma MK, Ervin KR, Horwitz DL. Rapid changes in postprandial blood glucose produce concentration differences at finger, forearm, and thigh sampling sites. Diabetes Care. 2002 Jun;25(6):961-4. doi: 10.2337/diacare.25.6.961.
PubMed 12032099Estruch R, Martinez-Gonzalez MA, Corella D, Salas-Salvado J, Ruiz-Gutierrez V, Covas MI, Fiol M, Gomez-Gracia E, Lopez-Sabater MC, Vinyoles E, Aros F, Conde M, Lahoz C, Lapetra J, Saez G, Ros E; PREDIMED Study Investigators. Effects of a Mediterranean-style diet on cardiovascular risk factors: a randomized trial. Ann Intern Med. 2006 Jul 4;145(1):1-11. doi: 10.7326/0003-4819-145-1-200607040-00004.
PubMed 16818923Granfeldt Y, Hagander B, Bjorck I. Metabolic responses to starch in oat and wheat products. On the importance of food structure, incomplete gelatinization or presence of viscous dietary fibre. Eur J Clin Nutr. 1995 Mar;49(3):189-99.
PubMed 7774535Halton TL, Willett WC, Liu S, Manson JE, Albert CM, Rexrode K, Hu FB. Low-carbohydrate-diet score and the risk of coronary heart disease in women. N Engl J Med. 2006 Nov 9;355(19):1991-2002. doi: 10.1056/NEJMoa055317.
PubMed 17093250Hatonen KA, Simila ME, Virtamo JR, Eriksson JG, Hannila ML, Sinkko HK, Sundvall JE, Mykkanen HM, Valsta LM. Methodologic considerations in the measurement of glycemic index: glycemic response to rye bread, oatmeal porridge, and mashed potato. Am J Clin Nutr. 2006 Nov;84(5):1055-61. doi: 10.1093/ajcn/84.5.1055.
PubMed 17093157Hu FB. Diet and cardiovascular disease prevention the need for a paradigm shift. J Am Coll Cardiol. 2007 Jul 3;50(1):22-4. doi: 10.1016/j.jacc.2007.04.027. Epub 2007 Jun 18. No abstract available.
PubMed 17601540Hu FB. Plant-based foods and prevention of cardiovascular disease: an overview. Am J Clin Nutr. 2003 Sep;78(3 Suppl):544S-551S. doi: 10.1093/ajcn/78.3.544S.
PubMed 12936948
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01929551
- Acronym / sponsor ID
- IGPMJP2013-CINCO
- Conditions
- Glucose Intolerance
- Keywords
- glycemic index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Instituto Tecnologico y de Estudios Superiores de MontereyUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 28 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Mango puree and pear juice beverage | Other | Other: Mango puree and pear juice beverageParticipants will drink 450 milliliters of the juice at time 0. |
| Commercial mango juice | Other | Other: Commercial mango juiceParticipants will drink 450 milliliters of the juice at time 0. |
| Fresh natural mango | Other | Other: Fresh natural mangoParticipants will eat 400 to 500 grams of frozen mango pulp, along with 250 milliliters of water at time 0. |
| Frozen natural mango | Other | Other: Frozen natural mangoParticipants will eat 400 to 500 grams of frozen mango pulp, along with 250 milliliters of water at time 0. |
| Processed natural mango pulp | Other | Other: Processed natural mango pulpParticipants will eat 400 to 500 grams of frozen mango pulp, along with 250 milliliters of water at time 0. |
| Mix of natural mango and pear | Other | Other: Mix of natural mango and pearParticipants 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. |
| 50 grams glucose load | Other | Other: 50 grams glucose loadParticipants will drink 250 milliliters of the standard glucose load at time 0. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mango puree and pear juice beverageAlso: Determination of glycemic index of MPPJB.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 | Mango puree and pear juice beverage |
| Commercial mango juiceAlso: Determination of glycemic index of commercial mango juiceCapillary 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 | Commercial mango juice |
| Fresh natural mangoAlso: Determination of glycemic index of fresh natural mangoCapillary 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 | Fresh natural mango |
| Frozen natural mangoAlso: Determination of glycemic index of frozen natural mangoCapillary 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 | Frozen natural mango |
| Processed natural mango pulpAlso: Determination of glycemic index of PNMP.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 | Processed natural mango pulp |
| Mix of natural mango and pearAlso: Determination of glycemic index for mix of NMP.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 | Mix of natural mango and pear |
| 50 grams glucose loadAlso: Determination of glycemic index for 50 grams glucose loadCapillary 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 | 50 grams glucose load |
Primary outcome
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.
6 secondary outcomes
Glycemic index of a commercial mango juice
Time frame: 8 days
Glycemic index of natural fresh mango
Time frame: 8 days
Glycemic index of natural frozen mango pulp
Time frame: 8 days
Glycemic index of processed natural mango pulp
Time frame: 8 days
glycemic index of a mixture of fresh mango 73 percent and fresh pear 27 percent
Time frame: 8 days
glycemic index of a 50 gram glucose load
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2014.
- BackgroundBrand JC, Holt S, Saveny and Hanksy J. Plasma glucose correlates inversely with satiety and CCK. Proc Nutr Soc Aust 1990; 15: 209 (abstr).
- Background: PubMed 17003313Brock DW, Davis CK, Irving BA, Rodriguez J, Barrett EJ, Weltman A, Taylor AG, Gaesser GA. A high-carbohydrate, high-fiber meal improves endothelial function in adults with the metabolic syndrome. Diabetes Care. 2006 Oct;29(10):2313-5. doi: 10.2337/dc06-0917. No abstract available.
- Background: PubMed 19079901Brouns F, Bjorck I, Frayn KN, Gibbs AL, Lang V, Slama G, Wolever TM. Glycaemic index methodology. Nutr Res Rev. 2005 Jun;18(1):145-71. doi: 10.1079/NRR2005100.
- Background: PubMed 22027051Carlson JJ, Eisenmann JC, Norman GJ, Ortiz KA, Young PC. Dietary fiber and nutrient density are inversely associated with the metabolic syndrome in US adolescents. J Am Diet Assoc. 2011 Nov;111(11):1688-95. doi: 10.1016/j.jada.2011.08.008.
- Background: PubMed 14512776Carlson JJ, Monti V. The role of inclusive dietary patterns for achieving secondary prevention cardiovascular nutrition guidelines and optimal cardiovascular health. J Cardiopulm Rehabil. 2003 Sep-Oct;23(5):322-33. doi: 10.1097/00008483-200309000-00001. No abstract available.
- BackgroundCarlson 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.
- Background: PubMed 16205465Delzenne NM, Cani PD. A place for dietary fibre in the management of the metabolic syndrome. Curr Opin Clin Nutr Metab Care. 2005 Nov;8(6):636-40. doi: 10.1097/01.mco.0000171124.06408.71.
- Background: PubMed 19026937Dubnov-Raz G, Berry EM. The dietary treatment of obesity. Endocrinol Metab Clin North Am. 2008 Dec;37(4):873-86. doi: 10.1016/j.ecl.2008.08.002.
- Background: PubMed 12032099Ellison JM, Stegmann JM, Colner SL, Michael RH, Sharma MK, Ervin KR, Horwitz DL. Rapid changes in postprandial blood glucose produce concentration differences at finger, forearm, and thigh sampling sites. Diabetes Care. 2002 Jun;25(6):961-4. doi: 10.2337/diacare.25.6.961.
- Background: PubMed 16818923Estruch R, Martinez-Gonzalez MA, Corella D, Salas-Salvado J, Ruiz-Gutierrez V, Covas MI, Fiol M, Gomez-Gracia E, Lopez-Sabater MC, Vinyoles E, Aros F, Conde M, Lahoz C, Lapetra J, Saez G, Ros E; PREDIMED Study Investigators. Effects of a Mediterranean-style diet on cardiovascular risk factors: a randomized trial. Ann Intern Med. 2006 Jul 4;145(1):1-11. doi: 10.7326/0003-4819-145-1-200607040-00004.
- Background: PubMed 7774535Granfeldt Y, Hagander B, Bjorck I. Metabolic responses to starch in oat and wheat products. On the importance of food structure, incomplete gelatinization or presence of viscous dietary fibre. Eur J Clin Nutr. 1995 Mar;49(3):189-99.
- Background: PubMed 17093250Halton TL, Willett WC, Liu S, Manson JE, Albert CM, Rexrode K, Hu FB. Low-carbohydrate-diet score and the risk of coronary heart disease in women. N Engl J Med. 2006 Nov 9;355(19):1991-2002. doi: 10.1056/NEJMoa055317.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leticia Elizondo-Montemayor, MD principal investigator
Clinical Nutrition and Obesity Research Center. TEC Salud, School of Medicine and Health Sciences. Instituto Tecnologico y de Estudios Superiores de Monterrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mango puree and pear juice beverage, Commercial mango juice and Fresh natural mango in people with Glucose Intolerance, run by Instituto Tecnologico y de Estudios Superiores de Monterey at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic index of mango puree with natural pear juice beverage (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01929551, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2014.