Metabolomic Evaluation of the Impact of Rocchetta Water on the Skin of Healthy Patients Through the Innovative Method of Artificial Intelligence.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Lipidomics
研究概览
简要总结
Evaluation of changes in skin metabolism after one month of intake of Acqua Rocchetta (water A) vs bicarbonate-calcic mediomineral water (water B) (reprogramming effect on skin metabolism); Evaluation of urinary profiles after intake of Acqua Rocchetta (water A) vs bicarbonate-calcic mediomineral water (water B) and possible relation with skin metabolites.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Lipidomics
时间窗: three months
Different concentration in cutaneous lipids
次要结局
- Urinomics(three months)