Impact of Supplementation of Probiotics and Grape Marc on Psychological Well-being of Healthy Adults

NCT ID: NCT07265934

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-10
• Study Completion Date: 2025-09-01

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.

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group B

Functional bars administration

Group Type: ACTIVE_COMPARATOR

Probiotic bars

Intervention Type: OTHER

The functional bar contains two probiotic bacterial strains, Lacticaseibacillus rhamnosus IMC 501® and Lacticaseibacillus paracasei IMC 502® at a concentration of 10E9 live cells per gram in a 1:1 combination (SYNBIO, European patent EP 1743042) and 1% grape marc extract; Each participant received one box containing 30 bars, one bar per day for 4 weeks.

Group C

Dietary supplement administration

Group Type: ACTIVE_COMPARATOR

Probiotic capsules

Intervention Type: DIETARY_SUPPLEMENT

The dietary supplement consists of capsules containing two probiotic bacterial strains, Lacticaseibacillus rhamnosus IMC 501® and Lacticaseibacillus paracasei IMC 502® at a concentration of 10E9 live cells per gram in a 1:1 combination (SYNBIO, European patent EP 1743042) and 1% grape marc extract. Each participant received one bottle containing 30 capsules, one capsule per day for 4 weeks.

Interventions

Probiotic bars

The functional bar contains two probiotic bacterial strains, Lacticaseibacillus rhamnosus IMC 501® and Lacticaseibacillus paracasei IMC 502® at a concentration of 10E9 live cells per gram in a 1:1 combination (SYNBIO, European patent EP 1743042) and 1% grape marc extract; Each participant received one box containing 30 bars, one bar per day for 4 weeks.

Intervention Type: OTHER

Probiotic capsules

The dietary supplement consists of capsules containing two probiotic bacterial strains, Lacticaseibacillus rhamnosus IMC 501® and Lacticaseibacillus paracasei IMC 502® at a concentration of 10E9 live cells per gram in a 1:1 combination (SYNBIO, European patent EP 1743042) and 1% grape marc extract. Each participant received one bottle containing 30 capsules, one capsule per day for 4 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Synbiotec Srl

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Cristina Verdenelli

Role: PRINCIPAL_INVESTIGATOR

Synbiotec Srl

Locations

Centro Universitario Sportivo, University of Camerino

Camerino, Macerata, Italy

Countries

Italy

Other Identifiers

Rescue-bio

Identifier Type: -

Identifier Source: org_study_id