SkinNCT05033795
Metabolomic Evaluation of the Impact of Acqua Rocchetta on the Skin of Healthy Patients.
A study testing Water A and Water B in people with Skin, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 30 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin
- What is being tested?
- Water A and Water B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 29 Jun 2021to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 9Show fewer
- use of alcohol.
- pregnancy (verified by self-declaration) and/or breastfeeding
- allergy to the components of Leukopor
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCSS Istituto Ortopedico Galeazzi
Milan
Paolo Pigatto, Prof
About this study
Official title: 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.
Read the 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.
- Conditions
- Skin
- Being tested
- Water A, Water B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water ADietary supplement
2 L of water A per day
Water BDietary supplement
2 L of water B per day
| Study group | Role | What they receive |
|---|---|---|
| Water A | Experimental | 2 L of water A per day Receives: Dietary Supplement: Water A |
| Water B | Other | 2 L of water B per day Receives: Dietary Supplement: Water B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipidomics
Different concentration in cutaneous lipids
Measured: three months
Secondary outcomes (1)
Urinomics
quantfication of different urinary metabolites
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start29 Jun 2021
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SkinStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo Pigatto, Prof, Principal investigator, IRCSS Istituto Ortopedico Galeazzi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033795
- Sponsor's protocol ID
- VALORE
- Status last verified
- Aug 2021
- First submitted
- 14 Jun 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomic Evaluation of the Impact of Rocchetta Water on the Skin of Healthy Patients Through the Innovative Method of Artificial Intelligence.
- ClinicalTrials.gov ID
- NCT05033795
- Acronym / sponsor ID
- VALORE
- Conditions
- Skin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water A | Experimental | Dietary Supplement: Water A2 L of water A per day |
| Water B | Other | Dietary Supplement: Water B2 L of water B per day |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water A2 L of water A per day | Dietary supplement | Water A |
| Water B2 L of water B per day | Dietary supplement | Water B |
Primary outcome
Lipidomics
Time frame: three months
Different concentration in cutaneous lipids
1 secondary outcome
Urinomics
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Pigatto, Prof principal investigator
IRCSS Istituto Ortopedico Galeazzi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water A and Water B in people with Skin, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Pigatto, Prof (0266214761, paolo.pigatto@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipidomics (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.