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临床试验/NCT05870930
NCT05870930已完成不适用

Bioavailability of Phenolic Compounds Following the Consumption of a Carob Beverage

Harokopio University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年2月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
Identification of putative polyphenol metabolites related to carob consumption.

研究概览

简要总结

This is an interventional, open-label, single-group, bioavailability postprandial study. The aim of the study is to evaluate the bioavailability of phenolic compounds of a beverage prepared with Cretan carob powder of the Imera cultivar in healthy individuals after consumption.

详细描述

This is an interventional, open-label, single-group, bioavailability postprandial study. The aim of the study is to evaluate the bioavailability of active constituents of a beverage with carob powder in healthy individuals after consumption. Fifteen apparently healthy male adults of normal body fat mass (non-obese) will be enrolled based on certain inclusion and exclusion criteria. After enrollment, the volunteers will undergo a medical and dietary assessment and will be instructed to follow a low-phytochemical diet (washout) for five consecutive days, excluding from their diet sources of phytochemicals, i.e., fruits, vegetables, legumes, coffee, tea. Compliance with the low-phytochemical diet will be assessed with a 24 h recall during and at the end of the washout period. On the day of the experiment following washout, volunteers will be given a carob beverage (blood samples will be collected 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0h postprandially). Time intervals 0-6h will be used for LC-ESI-MS/MS approach in order to identify putative polyphenol metabolites related to carob consumption.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • healthy male adults
  • normal body fat mass

排除标准

  • obesity (according to body fat mass)
  • Type 1 Diabetes, cardiovascular diseases, hypertension
  • thyroid disorder, liver disease, kidney disease
  • gastrointestinal disease
  • mental illness
  • use of nutraceutical supplements or natural products for weight loss
  • dietitians/nutritionists

研究组 & 干预措施

Carob beverage

Experimental

干预措施: Carob beverage (Other)

结局指标

主要结局

Identification of putative polyphenol metabolites related to carob consumption.

时间窗: Six hours

Polyphenol metabolites related to carob consumption identified using LC-ESI-MS/MS.

次要结局

未报告次要终点

研究者

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

Andriana C. Kaliora

Associate Professor

Harokopio University

研究点 (1)

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