Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 1:02 AM
Study NCT ID:
NCT07265934
Status:
COMPLETED
Last Update Posted:
2025-12-11
First Post:
2025-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Supplementation of Probiotics and Grape Marc on Psychological Well-being of Healthy Adults
Sponsor:
Synbiotec Srl
Organization:
Study Overview
Official Title:
Beneficial Effects of a Food Supplement in Capsule Form and a Functional Chocolate Bar, Both Containing SYNBIO® Probiotic Strains and Grape Marc Plant Extract, on Healthy Adults.
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
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:
Rescue-bio
Brief Summary:
An open-label, baseline-controlled (pre-post) pilot study to assess the maintenance and/or improvement of both physical and mental well-being in subjects who daily consume either a food supplement or a functional food containing both the SYNBIO® probiotic blend and the dry grape marc extract. A target number of 40 healthy individuals will be recruited who meet the inclusion and exclusion criteria, who will be assessed upon enrollment and who have signed informed consent. Subjects will be randomly assigned to either the functional food or dietary supplement groups.
Detailed Description:
The present clinical trial is a pilot open label, baseline-controlled (pre/post) experimental study, with a, a 2-week run-in period, 4-week intervention period and a further 2-week follow-up period without intervention to evaluate the potential prolonged effect of the functional products. Specifically, the supplementation should improve the parameters related to physical and mental well-being of subjects. Healthy adult participants were recruited and randomized into two treatment groups in a 1:1 ratio. Subjects will be randomly assigned to either the functional food or dietary supplement groups. The study will consist of three meetings at the coordinating center. The first visit will be for enrollment. Through an interview, the investigator will verify that the volunteer meets the inclusion criteria. The volunteer will receive an informed consent form to sign and the study protocol information sheet, which explains the study's progress in a simple and clear manner. The investigator will answer any questions and concerns the volunteer may have regarding the study. Subjects will be randomly assigned to either the functional food or dietary supplement group. Recruited subjects will be given questionnaires to complete independently. The second meeting will take place at the end of the month of taking the study products and will consist of the administration of the end-of-treatment questionnaires. The third and final meeting, two weeks after the end of treatment, will involve completing the questionnaires again to assess the possible persistence of the benefits that taking the products may have produced.
Study Oversight
Has Oversight DMC:
False
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?: