Clinical trial NCT02685124: Metabolomic Approach to Evaluate the Effect of Orange Juice Intake in Healthy Humans (METABORANGE).
Official title: Metabolomic Approach to Evaluate the Effect of Orange Juice Intake in Healthy Humans: a Comparative Study Between "Bahia" and "Cara Cara" Orange Varieties.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy Volunteers
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-02-18
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of intake of two orange juice varieties in healthy adults. The participants will receive "Bahia" orange juice, "Cara-Cara" orange juice or a isocaloric control drink in a cross-over study.

Detailed description: The consumption of fruits and vegetables is linked to a decrease in the incidence of chronic diseases. Citrus fruits represent the main source of bioactive compounds such as flavonoids, vitamin C and carotenoids in the brazilian diet.

Unlike the "Bahia", the "Cara Cara" variety which is a spontaneous mutation of "Washington navel" orange is characterized by a bright red pulp due to high levels of lycopene. This difference in the chemical composition may lead to a different biological activity and then a greater protective effect on health.

Since the biological effects generated from a food intake are the result of the interaction of various nutrients with different metabolic pathways, the investigators will apply the metabolomic approach to investigate the complex relationships between fruit intake, bioactive compounds and human metabolism. The investigators will propose to describe the metabolic pathways affected by orange juice intake and to identify biomarkers that can be used in nutritional interventions.

Eligibility criteria: Inclusion Criteria:

* Subjects like to drink orange juice

Exclusion Criteria:

* History of cardiovascular disease
* History of gastrointestinal, liver or kidney disease
* History of alcoholism
* Diabetes and metabolic diseases
* Pregnant, trying to became pregnant or breast feeding
* Smokers
* To make use of vitamin and mineral supplements, antibiotics, antiacids, any drugs

Primary outcomes:
measure: Qualitative changes in urinary metabolome will be evaluated by Gas Chromatography coupled to Mass Spectrometry (GC-MS) and Liquid Chromatography coupled to Mass Spectrometry (LC-MS).
timeFrame: Urine collection will be performed at time 0, after 3, 6 hours and 7 days of treatment.
Secondary outcomes:
measure: Changes in the antioxidant enzymes will be evaluated in serum samples in different time points.
timeFrame: Blood collection will be performed at time 0, after 3, 6 hours and 7 days of treatment
measure: Changes in the miRNAs expression will be evaluated in plasma samples in different time points.
timeFrame: Blood collection will be performed at time 0, after 3, 6 hours and 7 days of treatment
measure: Qualitative and quantitative changes in fecal metabolome will be evaluated by an untargeted metabolomic approach based on Nuclear Magnetic Resonance spectroscopy (NMR).
timeFrame: Feces collection will be performed at time 0 and after 7 days of treatment.
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Elisa Brasili, PhD
role: STUDY_DIRECTOR
References: