Metabolomic Evaluation of the Impact of Acqua Rocchetta on the Skin of Healthy Patients.

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Status: Unknown

Conditions: Skin

Treatments: Dietary Supplement: Water B; Dietary Supplement: Water A

Study type: Interventional

Funder types: Other

Identifiers

NCT05033795

VALORE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: Female

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups

Water A

Experimental group

Description:

2 L of water A per day

Treatment:

Dietary Supplement: Water A

Water B

Other group

Description:

2 L of water B per day

Treatment:

Dietary Supplement: Water B