Impact of Supplementation of Probiotics and Grape Marc on Psychological Well-being of Healthy Adults (Rescue-bio)

Synbiotec Srl

Status

Completed

Conditions

Healthy Participants

Treatments

Other: Probiotic bars

Dietary Supplement: Probiotic capsules

Study type

Interventional

Funder types

Industry

Identifiers

NCT07265934

Rescue-bio

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

men and women between 18 and 55 years;
healthy based on medical history;
commitment to comply with all study procedures;
have a moderate level of stress (score 13-20) based on the Cohen Perceived Stress Scale (PSS-10);
signing of informed consent.

Exclusion criteria

significant acute or chronic illnesses and/or an immunocompromised state
pregnant women who are breastfeeding or planning to become pregnant during the study period
subjects with clinically significant gastrointestinal tract disease, subjects with allergy or sensitivity to the active or inactive ingredients of the investigational product
subjects who had used antibiotics in the month prior to enrolment or who had used probiotics continuously in the two months prior to enrolment.