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.

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.

Study Overview

• Status: Recruiting
• Conditions: Skin
• Intervention / Treatment: Dietary supplement: Water A; Dietary supplement: Water B

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.

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paolo Pigatto, Prof; Phone Number: 0266214761; Email: paolo.pigatto@unimi.it

Study Locations

• Italy
  • Milano, Italy
    • Recruiting
    • IRCSS Istituto Ortopedico Galeazzi
    • Contact: Paolo Pigatto, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Water A; 2 L of water A per day	Dietary supplement: Water A; 2 L of water A per day
Other: Water B; 2 L of water B per day	Dietary supplement: Water B; 2 L of water B per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipidomics	Different concentration in cutaneous lipids	three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinomics	quantfication of different urinary metabolites	three months

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Galeazzi
• Investigators: Principal Investigator: Paolo Pigatto, Prof, IRCSS Istituto Ortopedico Galeazzi

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2021
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: VALORE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No