Table Olives Nutritional Intervention: Pharmacokinetics of Polyphenols and Pentacyclic Triterpenes and Assessment of Antioxidant, Cardiovascular and Anti-inflammatory Biomarkers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Stage 1: Peak trough fluctuation over one dosing interval at steady state (PTF)
研究概览
简要总结
Olives and olive oil are typical components of the Mediterranean diet being part of its cultural and gastronomic heritage. Since ancient times, olives have been used either for both, oil extraction or whole fruit consumption as table olives. Olive oil stands out from both the nutritional and the health point of view. However, the effect of table olives consumption remains almost unknown. The beneficial properties of olive oil have been initially ascribed to the high concentration of oleic acid. Nowadays, these positive effects have been attributed also to minor compounds such as polyphenols or pentacyclic triterpenes. Table olives contain a higher amount of both polyphenols and pentacyclic triterpenes than their oil, with the same healthy fatty acid profile. Therefore, the present intervention aims at investigating the pharmacokinetic of polyphenols and pentacyclic triterpenes after a single olive intake as well as the assessment of the effect of the consumption of olives during 30 days on the overall health status playing particular attention to the anti-inflammatory, antioxidant and cardiovascular biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index between 19 and 30 kg/m
- •Healthy on the basis of physical examination and routine biochemical and hematological laboratory determinations.
- •Free acceptance to participate in the study by obtains signed informed consent.
排除标准
- •Alcohol or drug abuse.
- •Heavy consumer of stimulating beverages (>5 coffees, teas, chocolate or cola drinks per day) and grapefruit juice.
- •Background of allergy, idiosyncrasy or hypersensitivity to drugs.
- •Intake of any medication within 2 weeks prior taking the study intervention (except for use of paracetamol in short-term symptomatic treatments), including over-the-counter products (including natural food supplements, vitamins and medicinal plants products), or any enzymatic inductor or inhibitor within 3 months before the drug administration.
- •Positive serology for hepatitis B, C or HIV.
- •Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological or neurological disease or other chronic diseases.
- •Having undergone major surgery during the previous 6 months.
- •Pregnancy or lactation status (if applied).
- •Participation in another clinical trial during the 3 months preceding the drug administration.
- •Donation of blood during the 4 weeks preceding the drug administration.
- •Acute illness four weeks before drug administration.
研究组 & 干预措施
60 Arbequina Table Olives
Pharmacokinetics Study
干预措施: Table Olives (Other)
120 Arbequina Table Olives
Pharmacokinetics Study
干预措施: Table Olives (Other)
60 Table Olives
Table Olives Nutritional Intervention
干预措施: Table Olives (Other)
Control
Control of Table Olives Nutritional Intervention
结局指标
主要结局
Stage 1: Peak trough fluctuation over one dosing interval at steady state (PTF)
时间窗: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 2: Plasma polyphenols concentration
时间窗: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: Catalase concentration
时间窗: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: Oxidized low-density lipoprotein concentration
时间窗: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 1: Clearance (Cl/F)
时间窗: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: AUC (0-t) dose normalized (AUC (0-t)/Dose)
时间窗: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 2: 8 isoprostane concentration
时间窗: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 1: AUC extrapolated to infinite time (AUC (0-∞)
时间窗: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Volume of distribution (Vd/ F)
时间窗: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Cmax dose normalized (Cmax/Dose)
时间窗: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Urine polyphenols concentration
时间窗: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 2: Plasma triterpenes concentration
时间窗: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: Malondialdehyde concentration
时间窗: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: Superoxide dismutase concentration
时间窗: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: Apolipoprotein A1 concentration
时间窗: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 1: Area under the curve from administration to last observed concentration at time (AUC (0-t)
时间窗: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Terminal elimination rate constant (Kel)
时间窗: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Urine triterpenes concentration
时间窗: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 2: Urine polyphenols concentration
时间窗: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 1: Maximum plasma concentration (Cmax)
时间窗: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Concentration at the end of the dosing interval (Ct)
时间窗: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Time until Cmax is reached (Tmax)
时间窗: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Percentage of AUC extrapolated (AUC%)
时间窗: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Plasma concentration half-life (t ½)
时间窗: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 2: Urine triterpenes concentration
时间窗: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: Glutathione peroxidase concentration
时间窗: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: F2A isoprostane concentration
时间窗: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: C-Reactive Protein concentration
时间窗: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: Tumor necrosis factor alpha concentration
时间窗: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: Lipoprotein-associated phospholipase A2 concentration
时间窗: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: Interleukin 1 concentration
时间窗: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: Apolipoprotein B100 concentration
时间窗: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: Interleukin 6 concentration
时间窗: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
次要结局
- Stage 2: Body weight(30 days dosing period or 30 days as control group separated by 15 days washout)
- Stage 2: Very low-density lipoprotein cholesterol concentration (VLDL-C)(30 days dosing period or 30 days as control group separated by 15 days washout)
- Stage 2: Urea concentration(30 days dosing period or 30 days as control group separated by 15 days washout)
- Stage 2: Aspartate aminotransferase concentration(30 days dosing period or 30 days as control group separated by 15 days washout)
- Stage 1 and 2: Systolic and diastolic blood pressure(Stage 1: 24 hour dosing period; 2 dosing periods each separated by 7 days washout, Stage 2: 30 days dosing period or 30 days as control group separated by 15 days washout)
- Stage 1 and 2: Respiratory rate(Stage 1: 24 hour dosing period; 2 dosing periods each separated by 7 days washout, Stage 2: 30 days dosing period or 30 days as control group separated by 15 days washout)
- Stage 2: High-density lipoprotein cholesterol concentration (HDL-C)(30 days dosing period or 30 days as control group separated by 15 days washout)
- Stage 2: Total cholesterol concentration(30 days dosing period or 30 days as control group separated by 15 days washout)
- Stage 2: Glucose concentration(30 days dosing period or 30 days as control group separated by 15 days washout)
- Stage 2: Alkaline phosphatase concentration(30 days dosing period or 30 days as control group separated by 15 days washout)
- Stage 1 and 2: Number of participants with treatment-related adverse events(30 days dosing period or 30 days as control group separated by 15 days washout)
- Stage 1 and 2: Heart rate(Stage 1: 24 hour dosing period; 2 dosing periods each separated by 7 days washout, Stage 2: 30 days dosing period or 30 days as control group separated by 15 days washout)
- Stage 2: Low-density lipoprotein cholesterol concentration (LDL-C)(30 days dosing period or 30 days as control group separated by 15 days washout)
- Stage 2: Triglyceride concentration(30 days dosing period or 30 days as control group separated by 15 days washout)
- Stage 2: Sodium concentration(30 days dosing period or 30 days as control group separated by 15 days washout)
- Stage 2: Alanine aminotransferase concentration(30 days dosing period or 30 days as control group separated by 15 days washout)
- Stage 2: Creatinine concentration(30 days dosing period or 30 days as control group separated by 15 days washout)
- Stage 2: Total proteins concentration(30 days dosing period or 30 days as control group separated by 15 days washout)