Identification of Aggregate Metabolic Phenotypes for the Main Dietary (Poly)Phenols and Assessment of the Factors Associated With Their Formation: Development of an Oral (Poly)Phenol Challenge Test (OPCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Identification of aggregate phenolic metabotypes
研究概览
简要总结
The study is a single-dose acute clinical trial aiming at identifying aggregate metabolic phenotypes for the main dietary (poly)phenols and assessing the factors associated with their formation.
The treatment consists of a nutritional challenge representative of the consumption of (poly)phenols in Europeans (so-called oral (poly)phenol challenge test, OPCT) and foresees the supplementation of three standardized tablets rich in (poly)phenols, prepared from various commercially available plant extracts constituting sources of specific (poly)phenols. Urinary excretion of (poly)phenol metabolites will be evaluated at 24 hours after tablet consumption or, for two subgroups of volunteers, at different time points for 24 hours upon tablet consumption. Blood pressure and heart rate will also be measured and anthropometric data collected. Information will be collected on genetic polymorphisms related to the metabolism of (poly)phenols, gene expression, standard cardiometabolic health biomarkers, cardiometabolic risk scores and gut microbiota profile, through the collection of urine, blood and stool samples. Volunteers will follow a (poly)phenol-free diet before and after the OPCT. To check compliance with food restrictions, a 24-hour recall will be carried out on each visit. For a sub-group of 50 subjects, 3 months after the first challenge, the OPCT will be repeated with further urinary and fecal collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult (18-74 y)
- •BMI 18.5-35 kg/m^2
排除标准
- •Past cardiovascular events and metabolic diseases including diabetes
- •Inflammatory bowel diseases or gastro-intestinal surgery
- •Renal (GFR<60 ml/min) or hepatic diseases (liver enzymes >2.5 fold higher)
- •Immunodeficiency or autoimmune diseases (other than well-compensated hypothyroidism)
- •Mental disorders
- •Antibiotic therapy within the last month
- •Food allergies
- •Pregnancy or lactation
结局指标
主要结局
Identification of aggregate phenolic metabotypes
时间窗: 24 hours post-consumption
Assessing the variability in the urinary excretion of phenolic metabolites among volunteers after consumption of (poly)phenol-rich tablets by using data-driven clustering.
次要结局
- Evaluating eicosanoids in urine samples(Baseline)
- Assessing transcriptomic signatures in peripheral blood mononuclear cells (PBMCs).(Baseline)
- Evolution over the time of the phenolic metabolites in urine samples(Different collection times for 24 hours (0; 0-3; 3-6; 6-9; 9-12; 12-24; 24 h))
- Assessing risk prediction scores(Baseline)
- Determining gut microbiota composition and functionality in fecal samples(Baseline)
- Untargeted urinary metabolomics(Baseline and 24 hours post-consumption)
- Evaluating trimethylamine N-oxide (TMAO) in urine and plasma samples(Baseline)
- Assessing anthropometric measurements(Baseline)
- Assessing DNA oxidation catabolites and branched fatty acyl esters of hydroxyl fatty acids (FAHFAs) in plasma samples(Baseline)
- Assessing blood pressure and heart rate(Baseline)
- Assessing the stability of aggregate phenolic metabotypes among individuals after 3 months(24 hours post-consumption in a test carried out after 3 months after the first supplementation)
- Assessing common cardiometabolic health biomarkers in blood samples(Baseline)
- Determining genetic differences among subjects(Baseline)
- Assessing dietary habits(Baseline)
研究者
Pedro M. Mena Parreño
Doctor
University of Parma