Metabolomic Evaluation of the Impact of Acqua Rocchetta on the Skin of Healthy Patients.
Metabolomic Evaluation of the Impact of Rocchetta Water on the Skin of Healthy Patients Through the Innovative Method of Artificial Intelligence.
研究概览
详细说明
This is a single-center, interventional, randomized controlled clinical trial conducted in healthy volunteers, in a double blind (subject and investigator).
The study will include age-matched female subjects who blindly take water A or water B, both marketed as food and not supplements, therefore evaluated annually by the relevant bodies (ASL, NAS and the Central Inspectorate for quality protection. and the repression of fraud on agri-food products (Icqrf)).
Women between 30 and 50 years old will be chosen who have a skin aging pattern very different from the male sex and governed by the oscillations of the menstrual cycle. A positive result on this population would be of crucial importance in terms of nutriceuticals and generalizability.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Paolo Pigatto, Prof
- 电话号码：0266214761
- 邮箱：paolo.pigatto@unimi.it
学习地点
-
-
-
Milano、意大利
- 招聘中
- IRCSS Istituto Ortopedico Galeazzi
-
接触：
- Paolo Pigatto, Prof
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- healthy female subjects
- in good health without disease with an ICD code in compliance with the World Health Organisation definition (a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity." )
- abstemious
- individuals who agree to sign an informed consent form
- individuals who follow an omnivorous diet
Exclusion Criteria:
- subjects outside the age range considered
- smokers and/or those with chronic or acute diseases coded by the ICD-10 system
- persons who do not consent to sign the informed consent form
- subjects who follow diets that are not omnivorous or with fattening / slimming purposes
- subjects undergoing hormonal or contraceptive hormonal therapies or in general drugs that may alter the hydroelectric balance
- persons with significant alterations in the menstrual cycle (amenorrhoea or dysmenorrhoea).
- use of alcohol.
- pregnancy (verified by self-declaration) and/or breastfeeding
- allergy to the components of Leukopor
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Water A
2 L of water A per day
|
2 L of water A per day
|
|
其他：Water B
2 L of water B per day
|
2 L of water B per day
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Lipidomics
大体时间：three months
|
Different concentration in cutaneous lipids
|
three months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Urinomics
大体时间：three months
|
quantfication of different urinary metabolites
|
three months
|
合作者和调查者
调查人员
- 首席研究员：Paolo Pigatto, Prof、IRCSS Istituto Ortopedico Galeazzi
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- VALORE
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.