Healthy ParticipantsRescue-bioNCT07265934
Impact of Supplementation of Probiotics and Grape Marc on Psychological Well-being of Healthy Adults
A study testing Probiotic bars and Probiotic capsules in people with Healthy Participants, run by Synbiotec Srl at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Probiotic bars and Probiotic capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jun 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Centro Universitario Sportivo, University of Camerino
Camerino, Macerata, 62032
About this study
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.
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.
Read the 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
- Being tested
- Probiotic bars, Probiotic capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic barsOther
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.
Probiotic capsulesDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Group B | Active comparator | Functional bars administration Receives: Other: Probiotic bars |
| Group C | Active comparator | Dietary supplement administration Receives: Dietary Supplement: Probiotic capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: After 4 weeks consumption of the study product
Secondary outcomes (13)
Assessment of sleep quality
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.
Measured: After 4 week consumption of the study product
Assessment of sleep quality
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.
Measured: After 2 weeks follow-up (week 6)
Assessment of physical activity
To evaluate the physical activity through the IPAQ (International Physical Activity Questionnaire) 4 week after consumption of the study product
Measured: After 4 weeks consumption of study product
Assessment of physical activity
To evaluate physical activity through the IPAQ (International Physical Activity Questionnaire) 2 weeks after the end of the study product consumption period
Measured: After 2 weeks follow-up (week 6)
Changes on health-related quality of life
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.
Measured: After 4 weeks consumption of the study product
Changes on health-related quality of life
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.
Measured: After 2 weeks follow-up (week 6)
Changes in quality of life
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).
Measured: After 4 weeks consumption of the study product
Changes in quality of life
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).
Measured: After 2 weeks follow-up (week 6)
Changes in intestinal function
To evaluate changes in intestinal function assessed according to the Bristol Stool Form Scale 4 weeks after consumption of the study product
Measured: After 4 weeks consumption of the study product
Changes in intestinal function
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
Measured: After 2 weeks follow-up (week 6)
Changes in gastrointestinal symptoms
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).
Measured: After 4 weeks consumption of the study product
Changes in gastrointestinal symptoms
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).
Measured: After 2 weeks follow-up (week 6)
Change in perceived stress levels
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).
Measured: After 2 weeks follow-up (week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start10 Jun 2025
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synbiotec Srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Cristina Verdenelli, Principal investigator, Synbiotec Srl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265934
- Sponsor's protocol ID
- Rescue-bio
- Acronym
- Rescue-bio
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07265934
- Acronym / sponsor ID
- Rescue-bio / Rescue-bio
- Conditions
- Healthy Participants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Synbiotec SrlIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B | Active comparator | Other: Probiotic barsFunctional bars administration |
| Group C | Active comparator | Dietary Supplement: Probiotic capsulesDietary supplement administration |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic barsThe 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. | Other | Group B |
| Probiotic capsulesThe 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. | Dietary supplement | Group C |
Primary outcome
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).
13 secondary outcomes
Assessment of sleep quality
Time frame: After 4 week consumption of the study product
Assessment of sleep quality
Time frame: After 2 weeks follow-up (week 6)
Assessment of physical activity
Time frame: After 4 weeks consumption of study product
Assessment of physical activity
Time frame: After 2 weeks follow-up (week 6)
Changes on health-related quality of life
Time frame: After 4 weeks consumption of the study product
Changes on health-related quality of life
Time frame: After 2 weeks follow-up (week 6)
Changes in quality of life
Time frame: After 4 weeks consumption of the study product
Changes in quality of life
Time frame: After 2 weeks follow-up (week 6)
Changes in intestinal function
Time frame: After 4 weeks consumption of the study product
Changes in intestinal function
Time frame: After 2 weeks follow-up (week 6)
Changes in gastrointestinal symptoms
Time frame: After 4 weeks consumption of the study product
Changes in gastrointestinal symptoms
Time frame: After 2 weeks follow-up (week 6)
Change in perceived stress levels
Time frame: After 2 weeks follow-up (week 6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Cristina Verdenelli principal investigator
Synbiotec Srl
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic bars and Probiotic capsules in people with Healthy Participants, run by Synbiotec Srl at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perceived stress levels (time frame: After 4 weeks consumption of the study product). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.