Randomized, Single-blind, Cross-over Pilot Study to Evaluate the Plasma Profile of Resveratrol Following an Oral Administration of Either Revifast® (Resveratrol From Polygonum Cuspidatum Extract Siebold & Zucc - Root Supported on Magnesium Hydration With a Weight Titer of Min. 30% Resveratrol) and Unsupported Pure Resveratrol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Evaluate the plasma concentration (micromolar concentration) of free resveratrol after administration of a tablet containing 150mg of resveratrol in either the Resv@MDH form or pure resveratrol dissolved in water.
研究概览
简要总结
The purpose of this study is to evaluate in 6 subjects aged between 18 and 60 years the peak blood (plasma profile) of two formulations, indistinguishable from each other, containing:
A) 180 mg natural Resveratrol (Polygonum cuspidatum 98%) B) 180 mg of Revifast® (resveratrol from supported on Magnesium hydroxide).
详细描述
The study will be randomized, controlled, single blind, cross-over, using the two granular compounds in capsules A and B, indistinguishable from each other, dissolved in aqueous solution and administered orally. either A:180 mg natural Resveratrol (Polygonum cuspidatum 98%) deriving from galenic preparation from the IRRE pharmacy - Istituto Riuniti based in Cannara in via Vittorio Emanuele II 23.
B) 180 mg of Revifast® (mixture of resveratrol from Polygonum cuspidatum extract Siebold & Zucc. Root supported on Magnesium hydroxide).
Cross-over refers to a type of clinical study in which each individual receives each of the treatments consecutively.
PHASE I: The subjects will be given, on the first day, in the morning on an empty stomach, a solution of content A or B obtained by dissolving the contents of the capsule in water which will then be taken orally. Samples of 2 ml of venous blood in a tube containing EDTA will be taken from a vein in the arm using a cannula at 0 min (fasting before administration), 15 min, 30 min, 60 min, 90 min, 120 min, 180 min .
WASH-OUT: 1 day. PHASE II: On the third day, the person who had taken the solution A will take the solution B, and vice versa, with the same methods and times described above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Single blind, the subject, but not the responsible investigator, does not know which of the two possible treatments he receives.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects naive to taking resveratrol, willing and able to understand and sign an informed consent;
- •Normal blood and chemical tests: blood count, lipid structure, kidney and liver function, inflammatory structure (Tnfα, reactive protein C, ESR), glycemic profile (Fasting blood glucose, HbA1C, insulinemia, Homa Index).
排除标准
- •Chronic pathologies (chronic renal failure, chronic hepatocellular insufficiency, autoimmune diseases, chronic inflammatory bowel diseases, diabetes mellitus, end-stage neoplasms, symptomatic chronic ischemic heart disease);
- •severe arterial hypertension;
- •High degree hypercholesterolaemia;
- •Up to two previous days' intake of red wine not exceeding 2 glasses / day for men and 1 glass / day for women;
- •Up to two previous days intake of foods containing resveratrol (red grapes, blueberries, dried fruit);
- •Age <18 years;
- •Poor compliance;
- •Taking dietary supplements containing antioxidants;
- •Untreated hypothyroidism;
- •Pregnant and breastfeeding women
结局指标
主要结局
Evaluate the plasma concentration (micromolar concentration) of free resveratrol after administration of a tablet containing 150mg of resveratrol in either the Resv@MDH form or pure resveratrol dissolved in water.
时间窗: 2 days
Analysis of the peak plasmatic profile of resveratrol in venous blood samples at specific time intervals and after administration of a tablet dissolved in water of two different formulations based on resveratrol. Timing of blood samples: (fasting before administration), 15 min, 30 min, 60 min, 90 min, 120 min, 180 min after oral administration. Samples of blood will be analyzed for pharmacological and metabolomic analysis of resveratrol and evaluate the concentration of resveratrol (micro molar) using a mass spectrometer.
次要结局
未报告次要终点
研究者
Bernard Fioretti
Associate Professor of General Phisiology
University Of Perugia