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

NCT07265934 | Completed

• 1 other identifier: Rescue-bio
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• Change in perceived stress levels

  to evaluate the effect of the probiotic products on perceived stress levels measured using the Perceived Stress Scale (PSS). 5-point scale from 0 (never) to 4 (very often).

  After 4 weeks consumption of the study product

Secondary Outcomes (13)

• Assessment of sleep quality

  After 4 week consumption of the study product

• Assessment of sleep quality

  After 2 weeks follow-up (week 6)

• Assessment of physical activity

  After 4 weeks consumption of study product

• Assessment of physical activity

  After 2 weeks follow-up (week 6)

• Changes on health-related quality of life

  After 4 weeks consumption of the study product

Study Arms (2)

Group B

ACTIVE COMPARATOR

Functional bars administration

Other: Probiotic bars

Group C

ACTIVE COMPARATOR

Dietary supplement administration

Dietary Supplement: Probiotic capsules

Interventions

Probiotic bars 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 B

Probiotic capsules 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.

Group C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Synbiotec Srl: lead

Study Sites (1)

Centro Universitario Sportivo, University of Camerino

Camerino, Macerata, 62032, Italy

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Maria Cristina Verdenelli

  Synbiotec Srl

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 5, 2025
• Study Start: June 10, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

IT (1)