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

December 4, 2025 updated by: Synbiotec Srl

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Macerata
      • Camerino, Macerata, Italy, 62032
        • Centro Universitario Sportivo, University of Camerino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group B
Functional bars administration
Other: 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.
Active Comparator: Group C
Dietary supplement administration
Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in perceived stress levels
Time Frame: After 4 weeks consumption of the study product
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of physical activity
Time Frame: After 4 weeks consumption of study product
To evaluate the physical activity through the IPAQ (International Physical Activity Questionnaire) 4 week after consumption of the study product
After 4 weeks consumption of study product
Assessment of physical activity
Time Frame: After 2 weeks follow-up (week 6)
To evaluate physical activity through the IPAQ (International Physical Activity Questionnaire) 2 weeks after the end of the study product consumption period
After 2 weeks follow-up (week 6)
Changes in intestinal function
Time Frame: After 4 weeks consumption of the study product
To evaluate changes in intestinal function assessed according to the Bristol Stool Form Scale 4 weeks after consumption of the study product
After 4 weeks consumption of the study product
Changes in intestinal function
Time Frame: After 2 weeks follow-up (week 6)
To evaluate changes in intestinal function assessed according to the Bristol Stool Form Scale 2 weeks after the end of the study product consumption period
After 2 weeks follow-up (week 6)
Assessment of sleep quality
Time Frame: After 4 week consumption of the study product
To evaluate the sleep quality through the PSQI (Pittsburgh Sleep Quality Index) 4 weeks after consumption of the study product. 0-3 interval scale , global PSQI score (range 0-21), the lower the PSQI global score, the better the sleep quality.
After 4 week consumption of the study product
Assessment of sleep quality
Time Frame: After 2 weeks follow-up (week 6)
To evaluate the sleep quality through the PSQI (Pittsburgh Sleep Quality Index) 2 weeks after the end of the study product consumption period. 0-3 interval scale , global PSQI score (range 0-21), the lower the PSQI global score, the better the sleep quality.
After 2 weeks follow-up (week 6)
Changes on health-related quality of life
Time Frame: After 4 weeks consumption of the study product
To evaluate changes on health-related quality of life through the GIQLI questionnaire 4 weeks after consumption of the study product. Scale from 0 to 4, a global score can be estimated that goes from 0 to 144. The higher the score, the better the result.
After 4 weeks consumption of the study product
Changes on health-related quality of life
Time Frame: After 2 weeks follow-up (week 6)
To evaluate changes on health-related quality of life through the GIQLI questionnaire 2 weeks after the end of the study product consumption period. Scale from 0 to 4, a global score can be estimated that goes from 0 to 144. The higher the score, the better the result.
After 2 weeks follow-up (week 6)
Changes in quality of life
Time Frame: After 4 weeks consumption of the study product
To evaluate changes in quality of life, assessed through the PGWBI questionnaire (The Psychologi-cal General Well-Being Index) 4 weeks after consumption of the study product. Score from 0 (severe stress) to 110 (well-being).
After 4 weeks consumption of the study product
Changes in quality of life
Time Frame: After 2 weeks follow-up (week 6)
To evaluate changes in quality of life, assessed through the PGWBI questionnaire (The Psychologi-cal General Well-Being Index) 2 weeks after the end of the study product consumption period. Score from 0 (severe stress) to 110 (well-being).
After 2 weeks follow-up (week 6)
Changes in gastrointestinal symptoms
Time Frame: After 4 weeks consumption of the study product
To evaluate changes in gastrointestinal symptoms assessed through the GSRS questionnaire (Gastrointestinal Symptom Rating Scale) 4 weeks after consumption of the study product. Seven-point Likert scale, from no discomfort (score 1) to very severe discomfort (score 7).
After 4 weeks consumption of the study product
Changes in gastrointestinal symptoms
Time Frame: After 2 weeks follow-up (week 6)
To evaluate changes in gastrointestinal symptoms assessed through the GSRS questionnaire (Gastrointestinal Symptom Rating Scale) 2 weeks after the end of the study product consumption period. Seven-point Likert scale, from no discomfort (score 1) to very severe discomfort (score 7).
After 2 weeks follow-up (week 6)
Change in perceived stress levels
Time Frame: After 2 weeks follow-up (week 6)
To evaluate perceived stress levels measured using the Perceived Stress Scale (PSS) 2 weeks after the end of the study product consumption period. 5-point scale from 0 (never) to 4 (very often).
After 2 weeks follow-up (week 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Synbiotec Srl

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maria Cristina Verdenelli, Synbiotec Srl

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Rescue-bio

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings