Metabolomic Approach to Evaluate the Effect of Orange Juice Intake in Healthy Humans: a Comparative Study Between "Bahia" and "Cara Cara" Orange Varieties.
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 21
- 主要终点
- 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).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects like to drink orange juice
排除标准
- •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
结局指标
主要结局
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).
时间窗: Urine collection will be performed at time 0, after 3, 6 hours and 7 days of treatment.
次要结局
- 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.)
研究者
Elisa Brasili
Post doc researcher
University of Sao Paulo