Clinical trial NCT05033795: Metabolomic Evaluation of the Impact of Acqua Rocchetta on the Skin of Healthy Patients.
Official title: Metabolomic Evaluation of the Impact of Rocchetta Water on the Skin of Healthy Patients Through the Innovative Method of Artificial Intelligence.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 48
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Lipidomics
timeFrame: three months
Secondary outcomes:
measure: Urinomics
timeFrame: three months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCSS Istituto Ortopedico Galeazzi
Study officials:
affiliation: IRCSS Istituto Ortopedico Galeazzi
name: Paolo Pigatto, Prof
role: PRINCIPAL_INVESTIGATOR
References: