Metabolomic Approach to Evaluate the Effect of Orange Juice Intake in Healthy Humans (METABORANGE).

Early Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Dietary Supplement: Orange juice

• Registration Number: NCT02685124
• Lead Sponsor: University of Sao Paulo

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2015-10
• Status Verified: 2016-02
• Study Completion: 2016-02
• Study First Submitted: 2016-02-04
• Study First Submitted QC: 2016-02-12
• Last Update Submitted: 2016-02-12
• Study First Posted: 2016-02-18
• Last Update Posted: 2016-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Subjects like to drink orange juice

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Isocaloric control drink	Orange juice	250 ml twice daily for 7 days
Bahia orange juice	Orange juice	250 ml twice daily for 7 days
Cara Cara orange juice	Orange juice	250 ml twice daily for 7 days

Primary Outcome Measures

Name	Time	Method
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).	Urine collection will be performed at time 0, after 3, 6 hours and 7 days of treatment.

Secondary Outcome Measures

Name	Time	Method
Changes in the antioxidant enzymes will be evaluated in serum samples in different time points.	Blood collection will be performed at time 0, after 3, 6 hours and 7 days of treatment
Changes in the miRNAs expression will be evaluated in plasma samples in different time points.	Blood collection will be performed at time 0, after 3, 6 hours and 7 days of treatment
Qualitative and quantitative changes in fecal metabolome will be evaluated by an untargeted metabolomic approach based on Nuclear Magnetic Resonance spectroscopy (NMR).	Feces collection will be performed at time 0 and after 7 days of treatment.