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

University of Sao Paulo

Status and phase: Completed; Early Phase 1

Conditions: Healthy Volunteers

Treatments: Dietary Supplement: Orange juice

Study type: Interventional

Funder types: Other

Identifiers

NCT02685124

CEP FCF 1097907

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 3 patient groups, including a placebo group

Bahia orange juice

Experimental group

Description:

250 ml twice daily for 7 days

Treatment:

Dietary Supplement: Orange juice

Cara Cara orange juice

Experimental group

Description:

250 ml twice daily for 7 days

Treatment:

Dietary Supplement: Orange juice

Isocaloric control drink

Placebo Comparator group

Description:

250 ml twice daily for 7 days

Treatment:

Dietary Supplement: Orange juice