Metabolomics Approach After Acute Intake of Grumixama Juice

NCT02790658 | Completed

• 1 other identifier: 17449613.8.0000.0067
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

Grumixama; Urolithins; Anthocyanins; Metabolomic Approach; Ellagitannins; Subjects

Outcome Measures

Primary Outcomes (2)

• Identification of metabolites in plasma and urine samples of 15 healthy volunteers after intake of grumixama juice by LCMS

  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.

  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

Secondary Outcomes (22)

• Urinary creatinine values of 15 healthy volunteers for data normalization

  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

  2 days

• Multivariate data analysis of metabolites identified in plasma and urine of 15 healthy volunteers after intake of grumixama juice by GCMS

  2 months

• Pathway analysis of metabolites identified by GCMS

  1 month

• Identification of anthocyanins in urine samples of 10 healthy volunteers by LCMS.

  2 months

Other Outcomes (11)

• Normal blood glycemia values of 15 volunteers before juice intake

  1 day

• Normal total cholesterol values of 15 volunteers before juice intake

  1 day

• Normal triglycerides values of 15 volunteers before juice intake

  1 day

Study Arms (1)

Grumixama Juice

OTHER

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.

Dietary Supplement: Intake of grumixama juice

Interventions

Intake of grumixama juice DIETARY_SUPPLEMENT

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.

Grumixama Juice

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• University of Auckland, New Zealand: collaborator

Related Publications (3)

• 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.

  PMID: 25005941 BACKGROUND

• 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.

  PMID: 21340048 BACKGROUND

• 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.

  PMID: 25990484 BACKGROUND

Study Officials

• Luciane L. Teixeira, MS

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Neuza M. Aymoto Hassimotto, PhD

  University of Sao Paulo

  STUDY CHAIR

• Franco M. Lajolo, PhD

  University of Sao Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 2, 2016
• First Posted: June 6, 2016
• Study Start: March 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: March 1, 2016
• Last Updated: June 14, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share