Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group B | Active Comparator | Functional bars administration |
|
| Group C | Active Comparator | Dietary supplement administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After 4 week consumption of the study product |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Maria Cristina Verdenelli | Synbiotec Srl | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Universitario Sportivo, University of Camerino | Camerino | Macerata | 62032 | Italy |
Not provided
| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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. |
| 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 | 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 | 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. | 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. | 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). | 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). | 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 | 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 | 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). | 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). | 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). | After 2 weeks follow-up (week 6) |
| D019602 |
| Food and Beverages |