Healthy Volunteers
Conditions
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.
Interventions
DIETARY_SUPPLEMENTOrange 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.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. |
Outcome results
None listed