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

Skin Clinical Trial

Official title:

Metabolomic Evaluation of the Impact of Rocchetta Water on the Skin of Healthy Patients Through the Innovative Method of Artificial Intelligence.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05033795
• Other study ID #: VALORE
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2021
• Est. completion date: September 2021

Study information

• Verified date: August 2021
• Source: Istituto Ortopedico Galeazzi
• Contact: Paolo Pigatto, Prof
• Phone: 0266214761
• Email: paolo.pigatto[@]unimi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Skin

Intervention

Dietary Supplement:
• Water A
2 L of water A per day
• Water B
2 L of water B per day

Locations

Country	Name	City	State
Italy	IRCSS Istituto Ortopedico Galeazzi	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipidomics	Different concentration in cutaneous lipids	three months
Secondary	Urinomics	quantfication of different urinary metabolites	three months