Metabolomic Approach to Evaluate the Effect of Orange Juice Intake in Healthy Humans: a Comparative Study Between "Bahia" and "Cara Cara" Orange Varieties.
Overview
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- University of Sao Paulo
- Enrollment
- 21
- Primary Endpoint
- 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).
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- All
- Accepts 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
- •To make use of vitamin and mineral supplements, antibiotics, antiacids, any drugs
Outcomes
Primary Outcomes
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).
Time Frame: Urine collection will be performed at time 0, after 3, 6 hours and 7 days of treatment.
Secondary Outcomes
- 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.)
Investigators
Elisa Brasili
Post doc researcher
University of Sao Paulo