NCT02685124

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

Metabolomic Approach to Evaluate the Effect of Orange Juice Intake in Healthy Humans: a Comparative Study Between "Bahia" and "Cara Cara" Orange Varieties.

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Orange juice	Three days before the start of the study, all participants will restrict their diet avoiding citrus fruits (orange, tangerine, lemon) and its derivatives (washout period), red fruits and vegetables (strawberry, red lettuce, red grape, tomate). The day before the sample collection will be provided a controlled dinner. A fasting for 8 hours will be required before blood and urine collection. All participants will divided into three groups: I (Cara Cara), II (Bahia), III (Isocaloric control drink). They will consume 250 ml of each drink twice daily for 7 consecutive days, with a washout period of 7 days among each intervention.

Timeline

• Start date: 2015-09-01
• Primary completion: 2015-10-01
• Completion: 2016-02-01
• First posted: 2016-02-18
• Last updated: 2016-02-18