Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-31 @ 7:09 AM
Study NCT ID:
NCT05033795
Status:
UNKNOWN
Last Update Posted:
2021-09-05
First Post:
2021-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolomic Evaluation of the Impact of Acqua Rocchetta on the Skin of Healthy Patients.
Sponsor:
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Organization:
Study Overview
Official Title:
Metabolomic Evaluation of the Impact of Rocchetta Water on the Skin of Healthy Patients Through the Innovative Method of Artificial Intelligence.
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: