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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
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.
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.
Centro Universitario Sportivo, University of Camerino
Camerino, Macerata, Italy
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).
Time frame: After 4 weeks consumption of the study product
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
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Masking
NONE
Enrollment
40
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: After 2 weeks follow-up (week 6)