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Metabolomics Approach After Acute Intake of Grumixama Juice

13. června 2016 aktualizováno: Luciane de Lira Teixeira, University of Sao Paulo

Metabolomics Approach After Acute Intake of Grumixama Juice (Eugenia Brasiliensis Lam)

Investigate the bioavailability of the main flavonoid, their colonic transformation and untargeted metabolites by an metabolomic approach following acute intake of a grumixama juice by humans.

Přehled studie

Postavení

Dokončeno

Podmínky

Zdravý

Intervence / Léčba

Doplněk stravy: Intake of grumixama juice

Detailní popis

The grumixama is a sweet and little cherry native of the South and Southeast regions of the Atlantic Forest of Brazil rich in phenolic compounds, mainly anthocyanins and ellagitannins. The objective of this study is Investigate the bioavailability of the main flavonoid, their colonic transformation and untargeted metabolites by an metabolomic approach following acute intake of a grumixama juice by humans.

Fifteen healthy subjects consumed grumixama juice at single dose, and urine and plasma samples were collected at different time points over 24 h period. The metabolites were analyzed by LC-ESI-MSn, LC-Q-TOF plasma and urine were also analyzed using untargeted metabolomic approach for amino acids and organic acids by GCMS.

Typ studie

Intervenční

Zápis (Aktuální)

Fáze

Nelze použít

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 49 let (Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Ženský

Popis

Inclusion Criteria:

Not have medical historical of cardiovascular, gastrointestinal, hepatic, renal, thyroid and/or diabetes dysfunction
Not be alcohol addicts, not use vitamins and other supplements
Not are using any kind of medication which affect the digestion and absorption of food, not be smokers
Not are pregnant.

Exclusion Criteria:

Have medical historical of cardiovascular, gastrointestinal, hepatic, renal, thyroid and/or diabetes dysfunction
Be alcohol addicts, use vitamins and other supplements
Are using any kind of medication which affect the digestion and absorption of food, be smokers
Are pregnant.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Přidělení: N/A
Intervenční model: Přiřazení jedné skupiny
Maskování: Žádné (otevřený štítek)

Počet zbraní

Zbraně a zásahy

Skupina účastníků / Arm	Intervence / Léčba
Jiný: Grumixama Juice Juice of grumixama purple fruit (Eugenia brasiliensis Lam.), which is good source of anthocyanins and ellagitannins. It was made with filtered water and sanitized fruits, with a blender. It was administered in single dose of 0.97 mg of anthocyanins and of 4.71 mg of ellagitannins per mL of juice. Which volunteers ingested 10 mL of juice per each Kg body weight. The metabolomic approach of plasma and urine samples following acute intake of grumixama juice was done by the collection of blood samples and urine, following the intake of grumixama juice.	Doplněk stravy: Intake of grumixama juice In the morning of experimental day after 10 h fasting, the volunteers have been collect the first urine in the morning and it was collected the blood before the intake of grumixama juice, after they drink the juice (0 min), it was collected blood at the times: 15 min, 30 min, 60 min,120 min, 240 min and 24 h; and it was also collected urine at the period: 0 -1h, 1 - 2h, 2 - 4h, 4 - 6 h, 6 - 12 h, 12 - 14 h, the first urine in the morning in the second day (24 h). During the period in the first 4 h of experiment the volunteers only intake the juice.

Skupina účastníků / Arm

Intervence / Léčba

Jiný: Grumixama Juice

Juice of grumixama purple fruit (Eugenia brasiliensis Lam.), which is good source of anthocyanins and ellagitannins. It was made with filtered water and sanitized fruits, with a blender. It was administered in single dose of 0.97 mg of anthocyanins and of 4.71 mg of ellagitannins per mL of juice. Which volunteers ingested 10 mL of juice per each Kg body weight.

The metabolomic approach of plasma and urine samples following acute intake of grumixama juice was done by the collection of blood samples and urine, following the intake of grumixama juice.

Doplněk stravy: Intake of grumixama juice

In the morning of experimental day after 10 h fasting, the volunteers have been collect the first urine in the morning and it was collected the blood before the intake of grumixama juice, after they drink the juice (0 min), it was collected blood at the times: 15 min, 30 min, 60 min,120 min, 240 min and 24 h; and it was also collected urine at the period: 0 -1h, 1 - 2h, 2 - 4h, 4 - 6 h, 6 - 12 h, 12 - 14 h, the first urine in the morning in the second day (24 h). During the period in the first 4 h of experiment the volunteers only intake the juice.

Co je měření studie?

Primární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Identification of metabolites in plasma and urine samples of 15 healthy volunteers after intake of grumixama juice by LCMS Časové okno: 2 months	The blood and urine samples were collected in the times describe in "Arms and Interventions". The samples were acidified and the anthocyanins and ellagitannins metabolites were extracted by SPE column, these metabolites extracted were concentrated and analyzed by LC-ESI-MSn (for phenolic acids and anthocyanins) and LC-Q-TOF (for urolithins), the mass fragments were expressed in m/z.	2 months
Identification of metabolites in plasma and urine samples of 15 healthy volunteers after intake of grumixama juice by GCMS. Časové okno: 2 months	The samples were collected as describe in "Arms and Interventions", but for urine samples were used only the samples collected at times 0 (before the juice intake), 0-1h, 1-2h, 2-4h and at 24h after intake. The plasma samples had their proteins precipitated with cold methanol, the metabolites were extracted, concentrated and the amino acids and organic acids were derivatized to became volatile and the samples were analyzed by GCMS. For urine samples the procedures were similar. The mass fragment profile of derivatized compounds were compared to a GCMS library.	2 months

Sekundární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Urinary creatinine values of 15 healthy volunteers for data normalization Časové okno: 15 days	The creatinine was measured in the 15 volunteers by using a commercial kit, the results obtained in mg/dL, and these values were transformed in mol/L. The values of creatinine were used to normalize the quantification data.	15 days
Cycle cell analysis in breast cancer cells treated with metabolites extracted from plasma and urine of 10 healthy volunteers after grumixama juice intake Časové okno: 2 days	Plasma and urine preparations were obtained by SPE extraction were dried and tested against breast cancer cells (MDA-MB 231) MDA-MB 231 cells were cultured in monolayer on Dulbecco Eagle modified culture medium supplemented with 10% fetal bovine serum, it was used 5x10-4 cells per well. The cells were incubated in a humidified chamber including 5% CO2 at 37ºC into a confluence of approximately 80%. Cells were further exposed to 200 mg/mL of urine and plasma extract preparations and phenolic compound standards (PCA, VA, HA, C3G) at 0.25 and 25 mg/mL, and maintained at 37ºC, under an atmosphere of 5% CO2 for 48 hours. Negative control was supplied with growth media and DMSO, and blank wells containing growth media only. The cells were lysed, the RNA were degraded and the DNA were marked with propidium iodide (1mg/mL) and the fluorescence was measure by flow cytometer and the cell cycle analysis were done by FlowJo. The results were expressed in % of cell for each cell cycle phase.	2 days
Multivariate data analysis of metabolites identified in plasma and urine of 15 healthy volunteers after intake of grumixama juice by GCMS Časové okno: 2 months	The peak intensity of each compound identified by GCMS were normalized by using a internal standards (D4-alanine). For urine these data also were normalized by creatinine values to normalize sample volume. Multivariate data analysis were done observe changes in these metabolites (amino acids and organic acids) during the 24h after grumixama juice intake. The data were analyzed by MetaboAnalyst 3.0 (http://www.metaboanalyst.ca/).	2 months
Pathway analysis of metabolites identified by GCMS Časové okno: 1 month	The samples were collected as describe in "Arms and Interventions", but for urine samples were used only the samples collected at times 0 (before the juice intake), 0-1h, 1-2h, 2-4h and at 24h after intake. The plasma samples had their proteins precipitated with cold methanol, the metabolites were extracted, concentrated and the amino acids and organic acids were derivatized to became volatile and the samples were analyzed by GCMS. For urine samples the procedures were similar. The mass fragment profile of derivatized compounds were compared to a GCMS library.	1 month
Identification of anthocyanins in urine samples of 10 healthy volunteers by LCMS. Časové okno: 2 months	The blood and urine samples were collected in the times describe in "Arms and Interventions". The samples were acidified and the anthocyanins metabolites were extracted by SPE column, these metabolites extracted were concentrated and analyzed by LC-ESI-MSn (for phenolic acids and anthocyanins) the mass fragments were expressed in m/z.	2 months
Identification of phenolic acids in plasma and urine samples of 10 healthy volunteers by LCMS Časové okno: 2 months	The blood and urine samples were collected in the times describe in "Arms and Interventions". The samples were acidified and the anthocyanins metabolites were extracted by SPE column, these metabolites extracted were concentrated and analyzed by LC-ESI-MSn (for phenolic acids and anthocyanins) the mass fragments were expressed in m/z.	2 months
Identification of urolithins in urine samples of 10 healthy volunteers by LCMS Časové okno: 2 months	The urine samples were collected in the times describe in "Arms and Interventions". The samples were acidified and the ellagitannins metabolites were extracted by SPE column, these metabolites extracted were concentrated and analyzed by LC-Q-TOF (for urolithins), the mass fragments were expressed in m/z.	2 months
Quantification of anthocyanins in urine samples of 10 healthy volunteers by HPLC Časové okno: 2 months	The urine samples were collected in the times describe in "Arms and Interventions". The samples were acidified and the anthocyanins metabolites were extracted by SPE column, these metabolites extracted were concentrated and analyzed by HPLC, the results were expressed nmol/mol of creatinine for urine samples. It was made to each volunteer, in each point of collection sample.	2 months
Quantification of urolithins in urine samples of 10 healthy volunteers by HPLC Časové okno: 2 months	The urine samples were collected in the times describe in "Arms and Interventions". The samples were acidified and the ellagitannins metabolites were extracted by SPE column, these metabolites extracted were concentrated and analyzed by HPLC, the results were expressed in mmol/mol of creatinine. It was made to each volunteer, in each point of collection sample.	2 months
Antiproliferative activity of metabolites extracted from plasma of 10 healthy volunteers after grumixama juice intake Časové okno: 2 days	Plasma preparations were obtained by SPE extraction were dried and tested against breast cancer cells (MDA-MB 231) MDA-MB 231 cells were cultured in monolayer on Dulbecco Eagle modified culture medium supplemented with 10% fetal bovine serum, it was used 5x10-4 cells per well. The cells were incubated in a humidified chamber including 5% CO2 at 37ºC into a confluence of approximately 80%. Cells were further exposed to 200 mg/mL of plasma extract preparations and phenolic compound standards (PCA, VA, HA, C3G) at 0.25 and 25 mg/mL, and maintained at 37ºC, under an atmosphere of 5% CO2 for 48 hours. Negative control was supplied with growth media and DMSO, and blank wells containing growth media only. Cells were marked with CFSE, and fluorescence was measured by flow cytometer. The results were expressed as % of proliferation inhibition.	2 days
Antiproliferative activity of metabolites extracted from urine of 10 healthy volunteers after grumixama juice intake Časové okno: 2 days	Urine preparations were obtained by SPE extraction were dried and tested against breast cancer cells (MDA-MB 231) MDA-MB 231 cells were cultured in monolayer on Dulbecco Eagle modified culture medium supplemented with 10% fetal bovine serum, it was used 5x10-4 cells per well. The cells were incubated in a humidified chamber including 5% CO2 at 37ºC into a confluence of approximately 80%. Cells were further exposed to 200 mg/mL of urine extract preparations and phenolic compound standards (PCA, VA, HA, C3G) at 0.25 and 25 mg/mL, and maintained at 37ºC, under an atmosphere of 5% CO2 for 48 hours. Negative control was supplied with growth media and DMSO, and blank wells containing growth media only. Cells were marked with CFSE, and fluorescence was measured by flow cytometer. The results were expressed as % of proliferation inhibition	2 days
Quantification of amino acids identified by GCMS Časové okno: 1 month	Standards curves of the amino acids that changed significantly after grumixama juice intake were made by GCMS. Through these standards curves the amino acids and organic acids were quantified and the results were expressed in mmol/μmol of creatinine for urine samples and mmol/mL of plasma.	1 month
Quantification of organic acids identified by GCMS Časové okno: 1 month	Standards curves of organic acids that changed significantly after grumixama juice intake were made by GCMS. Through these standards curves the organic acids were quantified and the results were expressed in mmol/μmol of creatinine for urine samples and mmol/mL of plasma.	1 month
Quantification of phenolic acids in plasma samples of 10 healthy volunteers by HPLC Časové okno: 2 months	The blood samples were collected in the times describe in "Arms and Interventions". The samples were acidified and the anthocyanins metabolites were extracted by SPE column, these metabolites extracted were concentrated and analyzed by HPLC, the results were expressed in μmol/mL of plasma. It was made to each volunteer, in each point of collection sample.	2 months
Quantification of phenolic acids in urine samples of 10 healthy volunteers by HPLC Časové okno: 2 months	The urine samples were collected in the times describe in "Arms and Interventions". The samples were acidified and the anthocyanins metabolites were extracted by SPE column, these metabolites extracted were concentrated and analyzed by HPLC, the results were expressed in mmol/mol of creatinine for urine samples. It was made to each volunteer, in each point of collection sample.	2 months
Pharmacokinetic parameters (AUC) of anthocyanins in urine of 10 healthy volunteers after intake of grumixama juice Časové okno: 1 month	Using the quantification results for each collection time was calculated the area under curve (AUC) of anthocyanins in urine (expressed in μmol/h).	1 month
Pharmacokinetic parameters (AUC) of phenolic acids in urine of 10 healthy volunteers after intake of grumixama juice Časové okno: 1 month	Using the quantification results for each collection time was calculated the area under curve (AUC) of phenolic acids in urine (expressed in mmol/h).	1 month
Pharmacokinetic parameters (AUC) of urolithins in urine of 10 healthy volunteers after intake of grumixama juice Časové okno: 1 month	Using the quantification results for each collection time was calculated the area under curve (AUC) of urolithins in urine (expressed in mmol/h).	1 month
Urine volume Časové okno: 1 day	The volume of each urine sample was measured in mL.	1 day
The total elimination of anthocyanins in urine of 10 healthy volunteers after intake of grumixama juice Časové okno: 1 month	The total elimination amount of anthocyanins was calculated using the urine volume and it was expressed in nmol.	1 month
The total elimination of phenolic acids in urine of 10 healthy volunteers after intake of grumixama juice Časové okno: 1 month	The total elimination amount of phenolic acids was calculated using the urine volume and it was expressed in µmol.	1 month
The total elimination of urolithins in urine of 10 healthy volunteers after intake of grumixama juice Časové okno: 1 month	The total elimination amount of urolithins was calculated using the urine volume and it was expressed in µmol.	1 month

Další výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Normal blood glycemia values of 15 volunteers before juice intake Časové okno: 1 day	The glycemia was measured in 15 volunteers to evaluate if the glycemia values were acceptable. The values were expressed in mg/dL.	1 day
Normal total cholesterol values of 15 volunteers before juice intake Časové okno: 1 day	The total cholesterol was measured in 15 volunteers to evaluate if the cholesterol values were acceptable. The values were expressed in mg/dL.	1 day
Normal triglycerides values of 15 volunteers before juice intake Časové okno: 1 day	The triglycerides were measured in 15 volunteers to evaluate if the triglycerides values were acceptable. The values were expressed in mg/dL.	1 day
Normal HDL values of 15 volunteers before juice intake Časové okno: 1 day	The HDL values were measured in 15 volunteers to evaluate if the HDL and LDL values were acceptable. The values were expressed in mg/dL.	1 day
Similar weight of 15 volunteers before juice intake Časové okno: 1 day	The weight was measured in 15 volunteers to calculate the dose of juice to be give to the volunteers and also to calculate the BMI. The results were expressed in Kg of body mass.	1 day
Similar height of 15 volunteers before juice intake Časové okno: 1 day	The height was measured in 15 volunteers to calculate the body index mass (BMI). The results were expressed in meters (m).	1 day
Similar BMI of 15 volunteers before juice intake Časové okno: 1 day	The height was measured in 15 volunteers to calculate the body index mass (BMI). The results were expressed in Kg/m2. This assessment was made to check if the volunteers had a similar BMI.	1 day
Normal LDL values of 15 volunteers before juice intake Časové okno: 1 day	The LDL values were measured in 15 volunteers to evaluate if the HDL and LDL values were acceptable. The values were expressed in mg/dL.	1 day
Normal serum creatinine of 15 volunteers before juice intake Časové okno: 1 day	The serum creatinine values were measured in 15 volunteers to evaluate if the values were acceptable. The values were expressed in mg/dL.	1 day
Alanine aminotransferase measures in serum samples of 15 volunteers before juice intake Časové okno: 1 day	The alanine aminotransferase was measured in the serum of 15 volunteers to evaluate if the values were acceptable. The values were expressed in U/L.	1 day
The aspartate transaminase measures in serum samples of 15 volunteers before juice intake Časové okno: 1 day	The aspartate transaminase was measured in the serum of 15 volunteers to evaluate if the values were acceptable. The values were expressed in U/L.	1 day

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Sao Paulo

Spolupracovníci

University of Auckland, New Zealand

Vyšetřovatelé

Vrchní vyšetřovatel: Luciane L. Teixeira, MS, University of Sao Paulo
Studijní židle: Neuza M. Aymoto Hassimotto, PhD, University of Sao Paulo
Studijní židle: Franco M. Lajolo, PhD, University of Sao Paulo

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. března 2014

Primární dokončení (Aktuální)

1. srpna 2014

Dokončení studie (Aktuální)

1. března 2016

Termíny zápisu do studia

První předloženo

2. dubna 2016

První předloženo, které splnilo kritéria kontroly kvality

30. května 2016

První zveřejněno (Odhad)

6. června 2016

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

14. června 2016

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

13. června 2016

Naposledy ověřeno

1. května 2016

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

17449613.8.0000.0067

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Španělsko

Metabolomics Approach After Acute Intake of Grumixama Juice