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This is a pilot exploratory study to investigate the effects of a probiotic Bifidobacterium longum NCC3001 intake on physiological and psychophysiological parameters related to stress in healthy individuals with mild to moderate stress level.
The purpose of the study is to explore the effects of a probiotic Bifidobacterium longum NCC3001 intake on physiological and psychophysiological parameters related to stress in healthy individuals with mild to moderate stress level.
The objectives is three:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic NCC3001 | Experimental | Sachets of NCC3001 and excipient (maltodextrin) to be administered orally every day for 6 weeks |
|
| Matched Placebo Comparator | Placebo Comparator | Sachets of matching placebo containing maltodextrin, yeast extract, cystein HCl and pea flour to be administered orally every day for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental probiotic product | Dietary Supplement | Probiotic supplementation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Salivary cortisol level | Salivary cortisol levels (nmol/L) before and after stressor | Before the stressor (time-point -20 minutes) and after the stressor (time-point +0 min, time-point +5 min, time-point +10 min, time-point +20 min, time-point +30 min, time-point +40 min) at both baseline and after 6 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Cortisol level from waking saliva samples | Cortisol level (nmol/L) from waking saliva samples collected 0, 15, 30, 45, 60 min after waking | Baseline and after 6 weeks treatment |
| Mean heart rate variability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Macé | Nestlé Institute of Health Science | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nestlé Research | Lausanne | Canton of Vaud | 1000 | Switzerland |
No plan
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Exploratory, randomized, placebo-controlled, 2-arms, double-blinded, parallel
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Unique coding
| Placebo comparator |
| Other |
Placebo |
|
Mean heart rate variability in the time (ms) measured continuously before, during and after the stressor by means of a portable a computer-based data acquisition system from Biopac, Inc
| Baseline and after 6 weeks treatment |
| Heart frequency | Heart frequency (Hz) measured continuously before, during and after the stressor by means of a portable a computer-based data acquisition system from Biopac, Inc | Baseline and after 6 weeks treatment |
| Mean skin conductance level | Mean skin conductance level (SCL, kΩ) measured continuously before, during and after the stressor by means of a portable a computer-based data acquisition system from Biopac, Inc | Baseline and after 6 weeks treatment |
| Self-reported measures before and after the stressor (PANAS) | Positive and negative affect scores (1-50) computed with the Positive and Negative Affect Schedule (PANAS) | Baseline and after 6 weeks treatment |
| Self-reported measures before and after the stressor (STAI-6) | Likert scores (1-4) for 6 mood dimensions: calm, tense, upset, relaxed, content, worry from the State Trait Anxiety Inventory 6-item short form (STAI-6) | Baseline and after 6 weeks treatment |
| Self-reported measures before, during and after the stressor (VAS) | VAS scores in mm (0-100) for subjective perception of the stress induction | Baseline and after 6 weeks treatment |
| Self-reported endpoints from standard questionnaires (PSS) | Perceived stress score (0-56) computed from the Perceived Stress Scale (PSS) | Baseline and after 6 weeks treatment |
| Self-reported endpoints from standard questionnaires (HADs) | Scores (0-21) of depression and anxiety computed from the Hospital Anxiety and Depression scale (HADs) | Baseline and after 6 weeks treatment |
| Self-reported endpoints from standard questionnaires (GSRS) | Scores from the Gastrointestinal Symptom-Rating Scale (GSRS): scores range from 1 to 7 and higher scores represent more discomfort | Baseline and after 6 weeks treatment |
| Self-reported endpoints from standard questionnaires (Pittsburgh Sleep Quality) | Sleep quality score from the Pittsburgh Sleep Quality Index questionnaire (score 0-21: the lower, the better sleep quality) | Baseline and after 6 weeks treatment |
| Probiotic in feces | Probiotic quantity in feces (genome copy number / million 16S copy number) | Baseline and after 6 weeks treatment |
| Microbiome related metabolites in stool, blood and urine | Microbiome related metabolites in stool, blood and urine | Baseline and after 6 weeks treatment |