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临床试验/NCT02767102
NCT02767102已完成不适用

Serum and Salivary Melatonin Levels and Antioxidant Power of Melatonin-rich Red Wine

University of Milan2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Serum and salivary melatonin after red wine intake (with or without MLT)

研究概览

简要总结

Melatonin (MLT) is a bioactive compound in red wine. The investigators will investigate the serum and salivary concentrations and antioxidant power of MLT after the intake of a glass of red wine. Twelve healthy volunteers were recruited to receive both 125 mL of red wine rich in MLT (10 ng mL-1) and without MLT (placebo), via a randomized, cross-over, and double-blind design. Serum and salivary MLT will be measured by liquid chromatography coupled to mass spectrometry (LC-MS) and enzyme-linked immunosorbent (ELISA), respectively. The ferric ion reducing antioxidant power (FRAP) will be analyzed.

详细描述

Melatonin (MLT) is a bioactive compound in red wine. No information is currently available on serum and salivary concentrations of MLT after drinking a glass of red wine, containing this indoleamine. Hence, in this study, the investigators will investigate the levels of MLT, in serum and saliva, soon after the intake of the MLT-rich red wine, and, correspondingly, they will verify the antioxidant power of the same biological fluids.

This will be a randomized, crossover, double-blind, placebo-controlled study with two treatment arms. Twelve healthy volunteers will be recruited to receive both 125 mL of red wine rich in MLT (10 ng mL-1) and without MLT (placebo), via a randomized, cross-over, and double-blind design.

Serum and salivary MLT will be measured by liquid chromatography coupled to mass spectrometry (LC-MS) and enzyme-linked immunosorbent (ELISA), respectively. The ferric ion reducing antioxidant power (FRAP) will be also analyzed.

For serum analyses, samples will be collected at 0, 30, 60 and 90 min. For saliva analyses, samples will be collected at 0, 45 and 120 min.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • to be healthy
  • to have normal weight (BMI 18.5-25.0)
  • to voluntarily accept to participate to the study.

排除标准

  • pregnancy and lactation for women;
  • supplementation with MLT and/or any other dietary supplement (vitamins, antioxidants, botanicals, phytochemicals)
  • systemic and chronic-degenerative diseases
  • abnormal hematological parameters
  • heavy smoking and alcohol drinking
  • high-intensity physical activity
  • under pharmacological treatment

结局指标

主要结局

Serum and salivary melatonin after red wine intake (with or without MLT)

时间窗: Time-course of the serum melatonin levels in healthy volunteer from 0 min to 90 min after administration of red wine. Time-course of the salivary melatonin levels in healthy volunteer from 0 min to 120 min after administration of red wine.

LC-MS analyses for serum and ELISA analyses for saliva

次要结局

  • Antioxidant power of saliva and serum after red wine intake (with or without MLT)(Time-course of the serum antioxidant power in healthy volunteer from 0 min to 90 min after administration of red wine. Time-course of the salivary antioxidant power in healthy volunteer from 0 min to 120 min after administration of red wine.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ANDREA SARDELLA

Associate Professor

University of Milan

研究点 (2)

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