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

NCT ID: NCT05033795

Last Updated: 2021-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-29

Study Completion Date

2021-09-30

Brief Summary

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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

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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.

Conditions

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Skin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Water A

2 L of water A per day

Group Type EXPERIMENTAL

Water A

Intervention Type DIETARY_SUPPLEMENT

2 L of water A per day

Water B

2 L of water B per day

Group Type OTHER

Water B

Intervention Type DIETARY_SUPPLEMENT

2 L of water B per day

Interventions

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Water A

2 L of water A per day

Intervention Type DIETARY_SUPPLEMENT

Water B

2 L of water B per day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paolo Pigatto, Prof

Role: PRINCIPAL_INVESTIGATOR

IRCSS Istituto Ortopedico Galeazzi

Locations

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IRCSS Istituto Ortopedico Galeazzi

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Paolo Pigatto, Prof

Role: CONTACT

0266214761

Facility Contacts

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Paolo Pigatto, Prof

Role: primary

Other Identifiers

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VALORE

Identifier Type: -

Identifier Source: org_study_id

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