Clinical trial NCT02790658: Metabolomics Approach After Acute Intake of Grumixama Juice
Official title: Metabolomics Approach After Acute Intake of Grumixama Juice (Eugenia Brasiliensis Lam)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Grumixama
Urolithins
Anthocyanins
Metabolomic Approach
Ellagitannins
Subjects
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: University of Auckland, New Zealand
First posted: 2016-06-06
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Identification of metabolites in plasma and urine samples of 15 healthy volunteers after intake of grumixama juice by LCMS
timeFrame: 2 months
measure: Identification of metabolites in plasma and urine samples of 15 healthy volunteers after intake of grumixama juice by GCMS.
timeFrame: 2 months
Secondary outcomes:
measure: Urinary creatinine values of 15 healthy volunteers for data normalization
timeFrame: 15 days
measure: Cycle cell analysis in breast cancer cells treated with metabolites extracted from plasma and urine of 10 healthy volunteers after grumixama juice intake
timeFrame: 2 days
measure: Multivariate data analysis of metabolites identified in plasma and urine of 15 healthy volunteers after intake of grumixama juice by GCMS
timeFrame: 2 months
measure: Pathway analysis of metabolites identified by GCMS
timeFrame: 1 month
measure: Identification of anthocyanins in urine samples of 10 healthy volunteers by LCMS.
timeFrame: 2 months
measure: Identification of phenolic acids in plasma and urine samples of 10 healthy volunteers by LCMS
timeFrame: 2 months
measure: Identification of urolithins in urine samples of 10 healthy volunteers by LCMS
timeFrame: 2 months
measure: Quantification of anthocyanins in urine samples of 10 healthy volunteers by HPLC
timeFrame: 2 months
measure: Quantification of urolithins in urine samples of 10 healthy volunteers by HPLC
timeFrame: 2 months
measure: Antiproliferative activity of metabolites extracted from plasma of 10 healthy volunteers after grumixama juice intake
timeFrame: 2 days
measure: Antiproliferative activity of metabolites extracted from urine of 10 healthy volunteers after grumixama juice intake
timeFrame: 2 days
measure: Quantification of amino acids identified by GCMS
timeFrame: 1 month
measure: Quantification of organic acids identified by GCMS
timeFrame: 1 month
measure: Quantification of phenolic acids in plasma samples of 10 healthy volunteers by HPLC
timeFrame: 2 months
measure: Quantification of phenolic acids in urine samples of 10 healthy volunteers by HPLC
timeFrame: 2 months
measure: Pharmacokinetic parameters (AUC) of anthocyanins in urine of 10 healthy volunteers after intake of grumixama juice
timeFrame: 1 month
measure: Pharmacokinetic parameters (AUC) of phenolic acids in urine of 10 healthy volunteers after intake of grumixama juice
timeFrame: 1 month
measure: Pharmacokinetic parameters (AUC) of urolithins in urine of 10 healthy volunteers after intake of grumixama juice
timeFrame: 1 month
measure: Urine volume
timeFrame: 1 day
measure: The total elimination of anthocyanins in urine of 10 healthy volunteers after intake of grumixama juice
timeFrame: 1 month
measure: The total elimination of phenolic acids in urine of 10 healthy volunteers after intake of grumixama juice
timeFrame: 1 month
measure: The total elimination of urolithins in urine of 10 healthy volunteers after intake of grumixama juice
timeFrame: 1 month
Other outcomes:
measure: Normal blood glycemia values of 15 volunteers before juice intake
timeFrame: 1 day
measure: Normal total cholesterol values of 15 volunteers before juice intake
timeFrame: 1 day
measure: Normal triglycerides values of 15 volunteers before juice intake
timeFrame: 1 day
measure: Normal HDL values of 15 volunteers before juice intake
timeFrame: 1 day
measure: Similar weight of 15 volunteers before juice intake
timeFrame: 1 day
measure: Similar height of 15 volunteers before juice intake
timeFrame: 1 day
measure: Similar BMI of 15 volunteers before juice intake
timeFrame: 1 day
measure: Normal LDL values of 15 volunteers before juice intake
timeFrame: 1 day
measure: Normal serum creatinine of 15 volunteers before juice intake
timeFrame: 1 day
measure: Alanine aminotransferase measures in serum samples of 15 volunteers before juice intake
timeFrame: 1 day
measure: The aspartate transaminase measures in serum samples of 15 volunteers before juice intake
timeFrame: 1 day
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Luciane L. Teixeira, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Neuza M. Aymoto Hassimotto, PhD
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Franco M. Lajolo, PhD
role: STUDY_CHAIR
References:
citation: Flores G, Dastmalchi K, Paulino S, Whalen K, Dabo AJ, Reynertson KA, Foronjy RF, D'Armiento JM, Kennelly EJ. Anthocyanins from Eugenia brasiliensis edible fruits as potential therapeutics for COPD treatment. Food Chem. 2012 Oct 1;134(3):1256-62. doi: 10.1016/j.foodchem.2012.01.086. Epub 2012 Feb 18.
citation: Reynertson KA, Yang H, Jiang B, Basile MJ, Kennelly EJ. Quantitative analysis of antiradical phenolic constituents from fourteen edible Myrtaceae fruits. Food Chem. 2008 Aug 15;109(4):883-890. doi: 10.1016/j.foodchem.2008.01.021.
citation: Teixeira Lde L, Bertoldi FC, Lajolo FM, Hassimotto NM. Identification of Ellagitannins and Flavonoids from Eugenia brasilienses Lam. (Grumixama) by HPLC-ESI-MS/MS. J Agric Food Chem. 2015 Jun 10;63(22):5417-27. doi: 10.1021/acs.jafc.5b01195. Epub 2015 Jun 2.