Metabolomic Evaluation of the Impact of Acqua Rocchetta on the Skin of Healthy Patients.
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2021
CompletedStudy Start
First participant enrolled
June 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedFirst Posted
Study publicly available on registry
September 5, 2021
CompletedSeptember 5, 2021
August 1, 2021
2 months
June 14, 2021
August 30, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Lipidomics
Different concentration in cutaneous lipids
three months
Secondary Outcomes (1)
Urinomics
three months
Study Arms (2)
Water A
EXPERIMENTAL2 L of water A per day
Water B
OTHER2 L of water B per day
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCSS Istituto Ortopedico Galeazzi
Milan, Italy
Study Officials
- PRINCIPAL INVESTIGATOR
Paolo Pigatto, Prof
IRCSS Istituto Ortopedico Galeazzi
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2021
First Posted
September 5, 2021
Study Start
June 29, 2021
Primary Completion
September 1, 2021
Study Completion
September 1, 2021
Last Updated
September 5, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share