Study of the Bioavailability of Hesperidine and Narirutin Provided by an Orange Juice to Identify Various Metabotypes in Prehypertensive and Hypertensive Grade 1 Individuals (FLAVOTIP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Percentage of absorption of hesperidin and narirutin
研究概览
简要总结
Flavonoids are polyphenolic compound mainly found in fruits and vegetables with numerous beneficial health effects as protection against cardiovascular diseases by an antihypertensive effect. The intestinal microbiota plays a key role in the metabolization of these compounds, so that differences in the composition and activity of the microbiota between individuals can generate different metabotypes. Flavonoids are found mainly in their conjugated form linked to the monosaccharide rhamnose and need to be metabolized by the intestinal bacteria, releasing the rhamnose, to be absorbed and, thus, bioactive. The bacterial enzyme responsible of rhamnose hydrolysis is α-L-rhamnosidase, whose activity can vary considerably depending on the composition of the microbiota. In fact, a great interindividual variability has been observed in the ability to absorb flavonoids, which allows to classify individuals according to the corresponding metabotype. In a previous project, the investigators confirmed the interindividual differences in the bioavailability of hesperidin and narirutin, two flavonoids naturally present in orange juice. However, the role of the intestinal microbiota in the metabolism of hesperidin and narirutin needs to be elucidated.
On this basis, the following hypothesis is presented: individuals with arterial hypertension can be classified into 3 different metabotypes that are the result of the ability to absorb hesperidin and narirutin, determined by the urinary excretion of their respective metabolites, and these metabotypes are associated with different microbiota enterotypes and with different fecal α-L-rhamnosidase activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women over 18 years of age
- •Systolic blood pressure ≤159 mm Hg
- •Sign the informed consent
排除标准
- •Body mass index (BMI) ≥ 35 kg / m2
- •Glucose > 126 mg / dL
- •Systolic blood pressure ≥ 160 mm Hg and diastolic blood pressure > 100 mm Hg or taking antihypertensive drugs
- •LDL cholesterol > 189 mg / dL
- •Triglycerides > 350 mg / dL
- •Anemia (hemoglobin ≤ 13 g / dL in men and ≤ 12 g / dL in women)
- •Tobacco addiction
- •Consumption of medicines, antioxidants or vitamin supplements 30 days before the study
- •Use of antibiotics during the last 30 days prior to the study
- •Consumption of prebiotics and / or probiotics during the 30 days prior to the study
- •Clinical history of gastrointestinal disease or presence of intestinal disorders at the time of inclusion
- •Chronic alcoholism
- •Monitoring a vegetarian diet
- •Pregnant or with intent to get pregnant
- •Being in breastfeeding period
- •Participation in a clinical trial or nutritional intervention study, in the last 30 days.
- •Inability to follow the study guidelines
结局指标
主要结局
Percentage of absorption of hesperidin and narirutin
时间窗: After 24 hours of juice consumption
Quantification of the metabolites derived from hesperidin and narirutin in basal and 24-hour urine samples, using Liquid Chromatography coupled to Mass Spectrometry (LC-QqQ). From the profile of metabolites detected in urine, the percentage of absorption of hesperidin and narirutin with respect to the amount ingested will be quantified to determine the metabotypes, based on the urinary excretion corresponding to each volunteer:
次要结局
- Gut microbiota composition(Basal)
- Enterotype classification(Basal)
- Creatinine levels(Basal and after 24 hours of juice consumption)
- Fecal α-L-rhamnosidase activity(Basal)